scholarly journals Vaginal progesterone supplementation in the management of preterm labor: A randomized controlled trial

2020 ◽  
Author(s):  
Ratanawadee Sirisangwon ◽  
Vorapong Phupong
Keyword(s):  
Preterm Birth ◽  
Gestational Age ◽  
Preterm Labor ◽  
Distress Syndrome ◽  
Controlled Trial ◽  
Latency Period ◽  
Antenatal Corticosteroids ◽  
Randomized Controlled ◽  
Vaginal Progesterone ◽  
Gestational Age At Delivery

Abstract BackgroundPreterm labor is a common obstetric complication and can lead to preterm delivery. Preterm birth or preterm delivery is the leading cause of neonatal morbidity and mortality, especially when preterm birth occurs at a gestational age less than 34 weeks. The primary objective in this study was to evaluate the effects of vaginal progesterone supplementation for the prolongation of the latency period in preterm labor. The secondary objectives were to evaluate gestational age at delivery, rates of preterm birth less than 34 and 37 weeks, obstetric outcomes, maternal compliance with medication use, and side effects.MethodsA randomized controlled trial was performed. Ninety women with preterm labor occurring at 24 to 34 weeks were either randomized to a vaginal progesterone group (44 women) receiving tocolytic and antenatal corticosteroids treatment combined with vaginal micronized progesterone (400 mg everyday) or to the no-progesterone group (46 women) receiving tocolytic and antenatal corticosteroids treatment only.ResultsLatency periods were more prolonged in the vaginal progesterone group than in the no-progesterone group (32.8 ± 18.7 vs. 25.8 ± 22.7 days, p = 0.045). Gestational age at delivery in the vaginal progesterone group was also higher than in the no-progesterone group (36.5 ± 2.9 vs. 34.9 ± 3.7 weeks, p = 0.022). There were significant reduction rates of preterm birth less than 34 weeks (13.6% vs. 39.1%, p = 0.012), low birth weight (29.5% vs. 50%, p = 0.048), neonatal respiratory distress syndrome (13.6% vs. 37%, p=0.021), and neonatal intensive care unit admission (6.8% vs. 28.3%, p = 0.017).ConclusionCombined treatment with vaginal progesterone 400 mg could prolong the latency period in preterm labor when compared with no progesterone. Further, this approach could decrease the rates of preterm birth less than 34 weeks, low birth weight, and neonatal respiratory distress syndrome.

scholarly journals Maintenance Treatment With Vaginal Progesterone or Placebo Delayed Preterm Birth More Efficiently Than Intravenous Tocolysis Alone – A Randomized Controlled Trial

2020 ◽  
Author(s):  
Ylva Vladic Stjernholm ◽  
Giovanna Marchini
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Preterm Labor ◽  
Maintenance Treatment ◽  
Reference Group ◽  
Controlled Trial ◽  
University Hospital ◽  
Pathogen Invasion ◽  
Randomized Controlled ◽  
Vaginal Progesterone

Abstract Objective To evaulate the efficacy of maintenance treatment with vaginal progesterone gel compared to placebo in women after the onset of preterm labor.Material and Methods A randomized controlled trial at a university hospital in Sweden in 2009 − 18. Healthy women with singleton pregnancy and early preterm labor were randomized to daily progesterone gel 90 mg (n = 29) or placebo (n = 29) after standard intravenous tocolysis. Women with intravenous tocolysis alone (n = 29) served as a reference group. Results The latency to delivery was 58 ± 34 days with progesterone, 64 ± 51 days with placebo and 2 ± 2 days in the reference group (p < 0.0001 respectively). The rate of preterm birth < 34 weeks was 34% after progesterone, 38% after placebo and 100% in the reference group (progesterone vs reference p = 0.01 and placebo vs reference p = 0.02). The composite neonatal morbidity and length of neonatal intensive care were lower after progesterone and placebo compared to the reference group (p < 0.0001 respectively).Conclusion Maintenance treatment with vaginal progesterone gel or placebo delayed preterm birth more efficiently than intravenous tocolysis alone, suggesting an effect of the placebo gel rather than of progesterone. We conclude, that the placebo gel reinforced the physiological barrier at the uterine cervix which protects the pregnancy from pathogen invasion and uterine infection leading to preterm birth.

Comparison of oral Dydrogesterone and 17-α hydroxyprogesterone caprate in the prevention of preterm birth

2021 ◽  
Author(s):  
Fahimeh Alizadeh ◽  
Malihe Mahmoudinia ◽  
Masoumeh Mirteimoori ◽  
Lila Pourali
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
Gestational Age ◽  
Preterm Labor ◽  
Latency Period ◽  
Obstetric Care ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Singleton Pregnancy ◽  
Gestational Age At Delivery

Abstract Background: Preterm birth (PTB) remains a significant problem in obstetric care. Progesterone supplements are believed to reduce the rate of preterm labor, but formulation, type of administration, and dosage varies in different studies. This study was performed to compare oral Dydrogesterone with intramuscular 17α-hydroxyprogesterone caproate (17α-OHPC) administration in prevention of PTB.Methods :In this randomized clinical trial, we studied 150 women with singleton pregnancy in 28Th-34Th Gestational week, who had received tocolytic treatment for preterm labor. Participants were divided to receive 30mg oral Dydrogesterone daily, 250mg intramuscular 17α-OHPC weekly, or no intervention (control group). All treatments were continued until 37Th Week or delivery, whichever occurred earlier. Obstetric outcomes, including latency period, gestational age at delivery, birth weight, neonatal intensive care unit (NICU) admission, and neonatal mortality were recorded. All patients were monitored biweekly until delivery.Results: Baseline gestational age was not significantly different between groups. Latency period was significantly longer in the progesterone group compared with Dydrogesterone and control groups (41.06±17.29 vs. 29.44±15.6 and 22.20±4.51 days, respectively; P<0.001). The progesterone group showed significantly better results compared with the other two groups, in terms of gestational age at delivery, birth weight, and Apgar score (P<0.001). None of the participants showed severe complications, stillbirth, or gestational diabetes.Conclusion: Progesterone caproate can strongly prolong the latency period and improve neonatal outcomes and therefore, is superior to oral Dydrogesterone in the prevention of PTB.

scholarly journals Oral dydrogesterone as an adjunctive therapy in the management of preterm labor: a randomized, double blinded, placebo‐controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Suparudeewan Thongchan ◽  
Vorapong Phupong
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Pregnant Women ◽  
Gestational Age ◽  
Pregnancy Outcomes ◽  
Preterm Labor ◽  
Controlled Trial ◽  
Latency Period ◽  
Gestational Age At Delivery ◽  
Double Blinded

Abstract Background Preterm birth is a major challenge in obstetric and perinatal care. It is the leading cause of neonatal death. The primary aim of this study was to evaluate the efficacy of oral dydrogesterone on latency period in managing preterm labor. The secondary aims were to evaluate the gestational age at delivery, percentage of preterm delivery before 34 weeks and 37 weeks, time to recurrent uterine contraction, pregnancy outcomes, neonatal outcomes, compliance and side effects. Methods This was a randomized, double blinded, placebo-controlled trial. Forty-eight pregnant women with preterm labor, singleton pregnancy, and gestational age of 24–34 weeks were enrolled into the study. The study group received 10 mg of oral dydrogesterone three times per day and the control group received placebo. All pregnant women received standard treatment with tocolytic and antenatal corticosteroids. Results The median latency periods were not significantly different between the dydrogesterone group (27.5 days) and placebo group (34 days, p = 0.45). Additionally, there were no differences in the gestational age at delivery, percentage of preterm delivery before 34 weeks and 37 weeks, pregnancy outcomes, neonatal outcomes, compliance and side effects. However, the time to the recurrence of uterine contractions in participants that had recurrent preterm labor was longer in the dydrogesterone group than in the placebo group (30.6 ± 12.3 vs 13.7 ± 5.0 days, p = 0.01). Conclusions Adjunctive treatment with 30 mg of oral dydrogesterone could not prolong latency period in preterm labor when compared to placebo. Trial registration ClinicalTrials.gov (Clinical trials registration: NCT 03935152, registered on May 2,2019).

Multiple Courses of Antenatal Corticosteroids for Preterm Birth (MACS): A Randomized Controlled Trial

2009 ◽  
Vol 64 (5) ◽  
pp. 288-289
Author(s):  
Kellie E. Murphy ◽  
Mary E. Hannah ◽  
Andrew R. Willan ◽  
Sheila A. Hewson ◽  
Arne Ohlsson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Antenatal Corticosteroids ◽  
Randomized Controlled

A randomized controlled trial of two-doses of vaginal progesterone 400 vs. 200 mg for prevention of preterm labor in twin gestations

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ahmed S. Abdel Wahab ◽  
Mostafa I. Abdelmonaem ◽  
Walaa M. Mahmoud ◽  
Ahmed E. Mansour
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Labor ◽  
Twin Pregnancy ◽  
Controlled Trial ◽  
Transvaginal Ultrasound ◽  
Statistical Significance ◽  
Average Weight ◽  
Randomized Controlled ◽  
Vaginal Progesterone ◽  
Second Twin

Abstract Objectives To compare between the effectiveness and safety of two different daily doses of vaginal progesterone (400 vs. 200 mg) in the prevention of preterm labor in twin pregnancy. Methods This is a prospective single-blinded randomized controlled trial conducted on 100 primi-gravida who had twin pregnancy and attended the antenatal clinic of a University hospital. They were equally and randomly allocated into two arms each containing 50 patients. Arm 1 received 400 mg and arm 2 received 200 mg vaginal progesterone daily at bed time starting from 14 weeks of pregnancy to 36 weeks. Transvaginal ultrasound was performed for assessment of the length of cervix at 14 and 22 weeks. Results Both arms of the current study were comparable regarding the cervical length at 14 and 22 weeks, mean gestational age at delivery, incidence of pre-term delivery, birth weight of the first twin. Second twin in addition to the average weight of both twins. No statistical significance differences between two arms regarding incidence of early neonatal death. NICU, mechanical ventilation, length of admission in NICU for the first twin. Second twin as well as both twins. Conclusions Vaginal progesterone treatment with different doses was tolerable, but wasn’t effective in the prevention of preterm labor in twin pregnancy.

Antenatal Azithromycin to Prevent Preterm Birth in Pregnant women with Vaginal Cerclage. A Randomized Controlled Trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Rania Hassan Mostafa ◽  
Sherif Ahmed Ashoush ◽  
Hassan Awwad Bayoumy ◽  
Wessam Kamal Lotfy Gabr
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Antenatal Care ◽  
Gestational Age ◽  
Mode Of Delivery ◽  
Perinatal Morbidity ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Gestational Age At Delivery

Abstract Background Preterm birth with its complications is one of the leading causes of perinatal morbidity and mortality, as well as maternal morbidity, especially in low and middle-income countries. Cervical cerclage is a well-established preventive tool in women at high risk of preterm birth; however, subclinical maternal infection might still cause failure of this method. Thus, adding prophylactic antibiotics, namely macrolides, could prevent preterm birth. Patients and methods This was a randomized controlled clinical trial involving two groups of women who underwent vaginal cerclage at Ain Shams University Maternity Hospital. One group received azithromycin 500mg one tablet orally once daily for 3 days every month from 14th week to 34th week gestation, in addition to routine antenatal care; while the other group received usual antenatal care without antibiotic prophylaxis after cerclage. Follow-up was done and we compared the outcomes in each group: gestational age at delivery, birth weight, mode of delivery, maternal complications, and perinatal complications. ClinicalTrials.gov Identifier NCT04278937. Results Gestational age at delivery was significantly higher in the azithromycin group (36.8weeks vs 34.1weeks; P = 0.017), with significant prolongation of gestation in the azithromycin group (23.7weeks vs 21.1weeks; P = 0.005). As regards birth weight, it was significantly higher in the azithromycin group (2932.6gm vs 2401.8gm; P = 0.006); however babies with low birth weight (birth weight &lt;2500gm) were non-significantly less frequent in the azithromycin group (3cases vs 7cases; P = 0.165). There was no significant difference between the two groups as regards other outcomes (miscarriage, stillbirth, neonatal intensive care unit admission, antepartum hemorrhage, postpartum pyrexia, need for blood transfusion). Conclusion Adding azithromycin as antenatal prophylaxis in women undergoing vaginal cerclage prolongs pregnancy and reduces risk of PTB, with slight increase in birth weight. However, there was no clear effect on incidence of low birth weight, or perinatal morbidity/mortality.

Sign in / Sign up

Export Citation Format

Share Document