scholarly journals Pregnancy outcomes from the global pharmacovigilance database on interferon beta-1b exposure

2020 ◽  
Vol 13 ◽  
pp. 175628642091031 ◽  
Author(s):  
Kerstin Hellwig ◽  
Fernando Duarte Caron ◽  
Eva-Maria Wicklein ◽  
Aasia Bhatti ◽  
Alessandra Adamo
Keyword(s):  
Cohort Study ◽  
Health Status ◽  
Spontaneous Abortion ◽  
Birth Defects ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Interferon Beta ◽  
Live Births ◽  
Congenital Birth Defects ◽  
Pharmacovigilance Database

Background: The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy. Methods: Pregnancy cases with exposure to interferon beta-1b reported to Bayer’s pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.e. prospective cases) were included in the analysis of this retrospective cohort study. Results: As of February 2018, 2581 prospective pregnancies exposed to interferon beta-1b were retrieved from the database; 1348 pregnancies had documented outcomes. The majority of outcomes [1106 cases (82.0%)] were live births. Health status was known for 981 live births (no known health status for 125). Most of the prospective pregnancies with known outcomes corresponded to live births with no congenital anomalies [896 cases (91.3%)]. Spontaneous abortion occurred in 160 cases (11.9%). Congenital birth defects were observed in 14/981 live births with known health status [1.4%, 95% confidence interval (CI) 0.78–2.38]. No consistent pattern in the type of birth defect was identified. Rates of both spontaneous abortion and birth defects were not higher than the general population. Conclusions: These PV data, the largest sample of interferon beta-1b-exposed patients reported to date, suggest no increase in risk of spontaneous abortion or congenital anomalies in women exposed during pregnancy.

scholarly journals SAT0117 TRIMESTER EXPOSURE AND PREGNANCY OUTCOMES IN WOMEN EXPOSED TO GOLIMUMAB – RESULTS FROM THE COMPANY PHARMACOVIGILANCE DATABASE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 992.2-992
Author(s):  
M. Otero-Lobato ◽  
S. Esslinger ◽  
S. Gabriel ◽  
M. Clark ◽  
P. Sheridan ◽  
...  
Keyword(s):  
Pregnancy Outcome ◽  
Birth Outcomes ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Spontaneous Abortions ◽  
Live Births ◽  
Elective Abortion ◽  
Induced Abortions ◽  
Pharmacovigilance Database ◽  
Inflammatory Bowel

Background:Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatologic indications and ulcerative colitis (UC).Objectives:To characterize pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented.Methods:This dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries.Results:Two hundred eight pregnancy cases (131 rheumatologic indications; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Of these 208 pregnancy cases, 119 were prospective and 89 were retrospective. Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective and 7 retrospective cases).For 183 of the 208 pregnancy cases with reported outcomes, the trimester of exposure to GLM was known. Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM through trimesters 1-3 and all resulted in live births (none with congenital anomalies; 1 infant with exposure to GLM and MTX was born preterm).Conclusion:The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.Disclosure of Interests:Marijo Otero-Lobato Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Suzan Esslinger Shareholder of: Johnson & Johnson, Consultant of: Johnson & Johnson, Novartis, Eli Lilly and Sandoz, Employee of: Johnson & Johnson, Susan Gabriel Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Merck, GSK, Michael Clark Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Pamela Sheridan Shareholder of: Johnson & Johnson, Roche Pharmaceuticals, Employee of: Johnson & Johnson, Roche, Novartis, Bayer, Anja Geldhof Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson

Pregnancy Outcomes of Wives of Chemical and Non-Chemical Weapons Exposed Veterans in Ahvaz, Iran: A Retrospective Cohort Study

2020 ◽  
Vol 35 (5) ◽  
pp. 477-481
Author(s):  
Leila Karimi ◽  
Andrew C. Miller ◽  
Alberto A. Castro Bigalli ◽  
Somaye Makvandi ◽  
Hossein Amini ◽  
...  
Keyword(s):  
Cohort Study ◽  
Spontaneous Abortion ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Long Term Effects ◽  
Secondary Infertility ◽  
Chemical Injury ◽  
Validated Questionnaire ◽  
Adverse Pregnancy

AbstractBackground:Sulphur mustard (HD) is a lipophilic caustic alkylating vesicant (blister agent) that has mutagenic and carcinogenic effects. Among the studied perturbations are long-term genitourinary (GU) and fertility effects. Approximately 50,000 Iranian soldiers and civilians were exposed to HD during the Iraq-Iran war (1980-1989). This study questioned the wives of Iraq-Iran war veterans to determine the effects of male HD-exposure on pregnancy complications, adverse pregnancy outcomes, and secondary infertility.Methods:A retrospective, survey-based cohort study was conducted of wives of Iranian military veterans that survived HD-associated injuries while serving in Ahvaz, Iran during the Iraq-Iran war (1980-1989), as compared to non-exposed veterans serving concomitantly. Patients were identified from a database of injured veterans maintained by the Foundation of Martyrs and Veterans Affairs (Iran) via a systematic random sampling method utilizing a random number table. Using a validated questionnaire, collected data included: demographics; type and severity of chemical injury; spouse’s obstetric history (pregnancy number, duration, complications, and outcomes before and after spouse’s chemical injury); and secondary infertility.Results:An increase in spontaneous abortion (P = .03), congenital anomalies (P < .0001), and secondary infertility (P = .003) were observed. These findings were greatest amongst those with HD injuries affecting >50% body surface area. No difference in stillbirth, premature birth, or low birth weight was observed.Conclusion:Exposure to HD in combat may have long-lasting fertility effects on soldiers and their spouses, including spontaneous abortion, congenital anomalies, and secondary infertility. Further investigation is needed into the long-term effects of HD exposure as well as methods to better protect soldiers.

scholarly journals Pregnancy outcomes in multiple sclerosis following subcutaneous interferon beta-1a therapy

2011 ◽  
Vol 17 (4) ◽  
pp. 423-430 ◽  
Author(s):  
Magnhild Sandberg-Wollheim ◽  
Enrica Alteri ◽  
Margaretha Stam Moraga ◽  
Gabrielle Kornmann
Keyword(s):  
Multiple Sclerosis ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Interferon Beta ◽  
Safety Data ◽  
Individual Case ◽  
In Utero ◽  
Available N ◽  
Safety Database ◽  
Live Births

Background: Women with multiple sclerosis (MS) are advised to discontinue interferon-beta therapy before trying to conceive. Unplanned pregnancies occur and risks related to exposure remain unclear. Methods: To determine pregnancy outcomes following interferon-beta therapy, we examined pregnancies from a global drug safety database containing individual case safety reports received in the post-marketing setting and safety data from clinical trials of subcutaneous interferon beta-1a in MS. Results: One thousand and twenty-two cases of exposure to subcutaneous interferon beta-1a during pregnancy were retrieved; 679 had a documented outcome. In cases for which exposure duration was available ( n = 231), mean time of foetal exposure to subcutaneous interferon beta-1a before treatment discontinuation was 28 days; most pregnancies (199/231; 86.1%) were exposed for ≤45 days. To avoid bias, only outcomes for prospective data ( n = 425) in pregnancies exposed to interferon beta-1a in utero were analysed further. Of these, 324 (76.2%) resulted in normal live births and four (0.9%) in live births with congenital anomalies (3 [0.7%] were ‘major’). Four (0.9%) pregnancies resulted in stillbirths (1 [0.2%] with foetal defects). There were 5 (1.2%) ectopic pregnancies, 49 (11.5%) spontaneous abortions and 39 (9.2%) elective terminations. Most pregnancies exposed to subcutaneous interferon beta-1a in utero were associated with normal live births. The rates of spontaneous abortion and major congenital anomalies in live births were in line with those observed in the general population. Conclusions: These data should be taken into account when considering options for women with MS who become pregnant or who are planning pregnancy while on treatment with subcutaneous interferon beta-1a.

scholarly journals 886. Pregnancy Outcomes Following Raltegravir Exposure

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S20-S21
Author(s):  
Hala Shamsuddin ◽  
Casey Raudenbush ◽  
Brittany Sciba ◽  
Erica N Gooch ◽  
Wayne Greaves ◽  
...  
Keyword(s):  
Spontaneous Abortion ◽  
Neural Tube ◽  
Neural Tube Defects ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Reproductive Potential ◽  
First Trimester ◽  
Hiv Treatment ◽  
Safety Database ◽  
Live Births

Abstract Background Safety data are needed regarding HIV treatment in women of reproductive potential and during pregnancy. This review is to evaluate pregnancy outcomes following prospective exposures (exposure report prior to knowledge of pregnancy outcome) to raltegravir during pregnancy. Methods Exposures to raltegravir during pregnancy reported cumulatively through March 26, 2019 to the internal safety database at Merck & Co., Inc. were reviewed. This database includes all reports of pregnancy from clinical trials sponsored by the company, spontaneous post-marketing reports, and noninterventional data sources. Prospective pregnancy reports were evaluated to determine rates of spontaneous abortion, stillbirth, and congenital anomalies, including neural tube defects. Data from two ongoing cohorts of pregnant women with HIV-1 infection, not included in the internal safety database, were also reviewed. Results A total of 2,508 prospective pregnancy reports with reported outcomes were identified among women exposed to raltegravir: 919 from the internal safety database (Table 1) and 1,589 from the UK/Ireland and French pregnancy cohorts. Among the 2,508 prospective pregnancy exposures, 945 were in the first trimester, of which 757 were within the periconception period (within 28 days of conception). Of the 471 documented first trimester exposures identified in the internal safety database, the rates of spontaneous abortion (6.9%), stillbirth (1%), and congenital anomalies (1.5% per live births) were similar to the rates observed in the background populations of the United States Among outcomes following any exposure, the rate of congenital anomalies was 3.4% per live births. There were no reports of neural tube defects identified within the internal safety database or among the cohort data. Conclusion Prospectively collected pregnancy outcome data do not suggest an association between raltegravir exposure and spontaneous abortion, stillbirth, or congenital anomalies, including neural tube defects. These data support the current HIV treatment recommendations for the use of raltegravir 400 mg twice daily in women of reproductive potential and during pregnancy. Disclosures All Authors: No reported Disclosures.

scholarly journals P599 Trimester exposure and pregnancy outcomes in women exposed to golimumab: Results from the company pharmacovigilance database

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S500-S501
Author(s):  
S Esslinger ◽  
M Otero-Lobato ◽  
S Gabriel ◽  
M Clark ◽  
P Sheridan ◽  
...  
Keyword(s):  
Pregnancy Outcome ◽  
Birth Outcomes ◽  
Pregnancy Outcomes ◽  
Spontaneous Abortions ◽  
Live Births ◽  
Elective Abortion ◽  
Induced Abortions ◽  
Pharmacovigilance Database ◽  
Inflammatory Bowel ◽  
Twin Pregnancies

Abstract Background Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatological indications and ulcerative colitis (UC). To characterise pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented. Methods These dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries. Results Two hundred eight pregnancy cases (131 rheumatological; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Three cases reported twin pregnancies. Of the 208 pregnancy cases, 119 were prospective and 89 were retrospective (Table 1). Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective/7 retrospective cases). For 183 of the 208 pregnancy cases with-reported outcomes, the trimester of exposure to GLM was known (Table 2). Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM throughout pregnancy (first, second and third trimester) and all resulted in live births. Conclusion The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare, but not associated with apparent clinical sequelae. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.

scholarly journals Emergency cervical cerclage and pregnancy outcomes

2017 ◽  
Vol 6 (5) ◽  
pp. 1993
Author(s):  
N. Nagendra Prasad ◽  
Sherin Annamma Thampan ◽  
R. Nagarathnamma
Keyword(s):  
Retrospective Study ◽  
Spontaneous Abortion ◽  
Pregnancy Outcomes ◽  
Cervical Dilatation ◽  
Second Trimester ◽  
Cervical Cerclage ◽  
Live Births ◽  
Term Delivery

Background: To evaluate the effectiveness and safety of emergency cervical cerclage in women who presented with advanced cervical changes such as cervical dilatation and bulging foetal membranes.Methods: This is a retrospective study on all women treated with cervical cerclage presented in the late second trimester with advanced cervical dilatation (2 to 4cms) for whom emergency cervical cerclage by McDonald technique.Results: Out of the 24 patients for whom emergency cervical cerclage was performed, three patients had spontaneous abortion after cervical cerclage, two had PROM and eight of these patients had term delivery. Twenty-one fetus were live born after the period of viability. Nine of these babies were admitted to NICU and 50 percent of the neonates required only regular perinatal care.Conclusions: Post emergency cervical cerclage, the outcome in terms of prolongation of pregnancy, live births and neonatal survival is better.

Oocyte activation by calcium ionophore and congenital birth defects: a retrospective cohort study

2016 ◽  
Vol 106 (3) ◽  
pp. 590-596.e2 ◽  
Author(s):  
Netanella Miller ◽  
Tal Biron-Shental ◽  
Rivka Sukenik-Halevy ◽  
Anat Hershko Klement ◽  
Reuven Sharony ◽  
...  
Keyword(s):  
Cohort Study ◽  
Birth Defects ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Calcium Ionophore ◽  
Oocyte Activation ◽  
Congenital Birth Defects

scholarly journals Impact of Inherited Bleeding Disorders on Maternal Bleeding and Other Pregnancy Outcomes: A Population-Based Cohort Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 493-493
Author(s):  
Arafat Ul Alam ◽  
Cynthia M. Wu ◽  
Venu Jain ◽  
Haowei Linda Sun
Keyword(s):  
Cohort Study ◽  
Pregnancy Outcomes ◽  
Research Funding ◽  
Population Based ◽  
Diagnostic Code ◽  
Bleeding Disorders ◽  
Live Births ◽  
Increased Risk ◽  
Significant Change

Abstract Introduction: Increasing rate of postpartum hemorrhage (PPH) has been observed between 2003 and 2010 in Canada. Given that bleeding disorders contribute to the risk of PPH, it is important to identify the current trend in PPH in the last decade and assess the impact of inherited bleeding disorders on maternal bleeding and other pregnancy outcomes. Methods: This is a retrospective population-based cohort study using the Alberta Pregnancy Birth Cohort. The creation of this cohort using multiple linked administrative databases has been previously described. Number of deliveries per year in Alberta, Canada was determined by Vital Statistics birth registry from 2010 to 2018 and was linked with Discharge Abstract Database (DAD) to identify cases of PPH and other pregnancy outcomes. PPH was defined as a blood loss of ≥500 ml following vaginal delivery or ≥1000 ml following Caesarean section, or as a diagnosis noted by a health care provider. All diagnoses and procedures were identified by International Classification of Diseases (ICD)-10 codes and Canadian Classification of Interventions (CCI) codes, respectively. Previous validation study of diagnostic code for PPH in DAD showed high sensitivity and specificity. Inherited bleeding disorders including von Willebrand disease, hemophilia carriers, platelet function disorder, and hereditary deficiencies of other coagulation factors were identified by presence of at least two ICD codes. All analyses were restricted to hospitalized deliveries with live births. Temporal trend of PPH rate was assessed by Mann-Kendall test. Univariate logistic regression analyses were used to compute odds of pregnancy outcomes among women with inherited bleeding disorders compared with those without at their index pregnancies during the study period. Results: Between 2010 to 2018, 311,657 women had a total of 452,846 pregnancies with live births. The mean age of the study cohort was 29 years. Most (90%) of them reached term pregnancies. The total number of PPH was 47,602 (10.5 per 100 deliveries). The rate of PPH did not have any significant change from 10.3 in 2010 (95% confidence interval [CI] 10.0-10.6) to 10.8 (95% CI 10.6 -11.1) in 2018 (P for trend =0.28) [Figure 1]. Among 311,657 women, 345 (0.1%) had a diagnosis of inherited bleeding disorders [Table 1]. Women with bleeding disorders were more likely to experience PPH (odds ratio [OR] 1.4; 95% CI 1.1-1.9), antepartum hemorrhage (OR 4.3; 95% CI 2.9-6.4) and had a 3-fold increased risk of undergoing hysterectomy (OR 3.1; 95% CI 1.8-5.2). The bleeding cohort had 3.8 (95% CI: 2.4-6.0) times greater risk of being transfused with blood products. We observed a trend towards higher odds of caesarean delivery in women with bleeding disorders compared with those without (OR 1.2, 95% CI 0.9-1.5), albeit not statistically significant. However, there was no significant difference in prolonged labor, obstetric hematoma, low birth weight baby and induced labour. Conclusion: Despite a rise in the rate of PPH between 2003-2010, we observed no significant change in the rate of PPH in Alberta between 2010-2018. Women with inherited bleeding disorders are at an increased risk of bleeding events during pregnancy and childbirth. Further investigation into quality of care among this patient population is ongoing to identify areas for improvement. Figure 1 Figure 1. Disclosures Wu: BMS-Pfizer: Honoraria, Research Funding; Leo Pharma: Honoraria; Pfizer: Honoraria; Servier: Honoraria; Bayer: Research Funding; Daiichi-Sankyo: Research Funding. Sun: Pfizer: Consultancy; Novo Nordisk: Consultancy; Bayer: Consultancy; Octapharma: Consultancy, Research Funding; Shire: Consultancy.

scholarly journals Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

2014 ◽  
Vol 58 (8) ◽  
pp. 4392-4398 ◽  
Author(s):  
Stephanie Padberg ◽  
Evelin Wacker ◽  
Reinhard Meister ◽  
Mary Panse ◽  
Corinna Weber-Schoendorfer ◽  
...  
Keyword(s):  
Spontaneous Abortion ◽  
Birth Defects ◽  
Pregnancy Outcomes ◽  
Odds Ratio ◽  
Time Window ◽  
First Trimester ◽  
Specific Pattern ◽  
Fetal Ultrasound ◽  
Crude Odds Ratio ◽  
Increased Risk

ABSTRACTFluoroquinolones are avoided during pregnancy due to developmental toxicity in animals. The aim of this study was to assess the fetal risk after intrauterine fluoroquinolone exposure. We performed an observational study of a prospectively ascertained cohort of pregnant women exposed to a fluoroquinolone during the first trimester. Pregnancy outcomes were compared to those of a cohort exposed to neither fluoroquinolones nor teratogenic or fetotoxic drugs. The outcomes evaluated were major birth defects (structural abnormalities of medical, surgical, or cosmetic relevance), spontaneous abortion, and elective termination of pregnancy. Pregnancy outcomes of 949 women with fluoroquinolone treatment were compared with those of 3,796 nonexposed controls. Neither the rate of major birth defects (2.4%; adjusted odds ratio [ORadj], 0.91; 95% confidence interval [CI], 0.6 to 1.5) nor the risk of spontaneous abortion (adjusted hazard ratio [HRadj], 1.01; 95% CI, 0.8 to 1.3) was increased. However, there was a nonsignificant increase in major birth defects after exposure to moxifloxacin (6/93, 6.5%; crude odds ratio [ORcrude], 2.40; 95% CI, 0.8 to 5.6). Neither a critical exposure time window within the first trimester nor a specific pattern of birth defects was demonstrated for any of the fluoroquinolones. The rate of electively terminated pregnancies was increased among the fluoroquinolone-exposed women (HRadj, 1.32; 95% CI, 1.03 to 1.7). The gestational ages at delivery and birth weights did not differ between groups. Our study did not detect an increased risk of spontaneous abortion or major birth defects. These reassuring findings support the recommendation to allow fluoroquinolone use in early pregnancy in selected cases. After the use of moxifloxacin, a detailed fetal ultrasound examination should be considered.

Chance of live birth: a nationwide, registry-based cohort study

2021 ◽  
Author(s):  
Astrid M Kolte ◽  
David Westergaard ◽  
Øjvind Lidegaard ◽  
Søren Brunak ◽  
Henriette Svarre Nielsen
Keyword(s):  
Cohort Study ◽  
Live Birth ◽  
Pregnancy Outcomes ◽  
Maternal Age ◽  
Obstetric Complications ◽  
Model Discrimination ◽  
Still Birth ◽  
Live Births ◽  
Pregnancy History ◽  
Ectopic Pregnancies

Abstract STUDY QUESTION Does the sequence of prior pregnancy events (pregnancy losses, live births, ectopic pregnancies, molar pregnancy and still birth), obstetric complications and maternal age affect chance of live birth in the next pregnancy and are prior events predictive for the outcome? SUMMARY ANSWER The sequence of pregnancy outcomes is significantly associated with chance of live birth; however, pregnancy history and age are insufficient to predict the outcome of an individual woman’s next pregnancy. WHAT IS KNOWN ALREADY Adverse pregnancy outcomes decrease the chance of live birth in the next pregnancy, whereas the impact of prior live births is less clear. STUDY DESIGN, SIZE, DURATION Nationwide, registry-based cohort study of 1 285 230 women with a total of 2 722 441 pregnancies from 1977 to 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS All women living in Denmark in the study period with at least one pregnancy in either the Danish Medical Birth Registry or the Danish National Patient Registry. Data were analysed using logistic regression with a robust covariance model to account for women with more than one pregnancy. Model discrimination and calibration were ascertained using 20% of the women in the cohort randomly selected as an internal validation set. MAIN RESULTS AND THE ROLE OF CHANCE Obstetric complications, still birth, ectopic pregnancies and pregnancy losses had a negative effect on the chance of live birth in the next pregnancy. Consecutive, identical pregnancy outcomes (pregnancy losses, live births or ectopic pregnancies) immediately preceding the next pregnancy had a larger impact than the total number of any outcome. Model discrimination was modest (C-index = 0.60, positive predictive value = 0.45), but the models were well calibrated. LIMITATIONS, REASONS FOR CAUTION While prior pregnancy outcomes and their sequence significantly influenced the chance of live birth, the discriminative abilities of the predictive models demonstrate clearly that pregnancy history and maternal age are insufficient to reliably predict the outcome of a given pregnancy. WIDER IMPLICATIONS OF THE FINDINGS Prior pregnancy history has a significant impact on the chance of live birth in the next pregnancy. However, the results emphasize that only taking age and number of losses into account does not predict if a pregnancy will end as a live birth or not. A better understanding of biological determinants for pregnancy outcomes is urgently needed. STUDY FUNDING/COMPETING INTEREST(S) The work was supported by the Novo Nordisk Foundation, Ole Kirk Foundation and Rigshospitalet’s Research Foundation. The authors have no financial relationships that could appear to have influenced the work. TRIAL REGISTRATION NUMBER N/A.

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