Progesterone Gel and Placebo were Equally Effective in Preventing Preterm Birth Among Women with Preterm Labor

2021 ◽  
Author(s):  
Ylva Vladic Stjernholm ◽  
Tomislav Vladic ◽  
Giovanna Marchini
Keyword(s):  
Preterm Birth ◽  
Preterm Labor ◽  
Neonatal Intensive Care ◽  
Maintenance Treatment ◽  
Controlled Trial ◽  
Neonatal Morbidity ◽  
Control Group ◽  
Pathogen Invasion ◽  
Prolonged Pregnancy ◽  
Randomised Controlled

Abstract Introduction The aim of this trial was to evaluate the effect of maintenance treatment with vaginal progesterone gel compared to placebo in preventing preterm birth after the onset of preterm labor.Methods A randomised controlled trial in Sweden in 2009 − 18. Women with preterm labor were randomized to daily doses of progesterone gel 90 mg (n = 29) or placebo (n = 29) after standard treatment with intravenous tocolytics. Women with intravenous tocolytics alone served as controls.Results The latency to delivery was 58 ± 34 days with progesterone and 64 ± 51 days with placebo (p = 0.83), compared to 2 ± 2 days in the control group (progesterone and placebo vs control p < 0.001). The rate of preterm birth before 34 weeks was 34 % after progesterone and 38 % after placebo (p = 0.34) compared to 100 % in the control group (p < 0.001 respectively). The composite neonatal morbidity (p = 0.65) and neonatal intensive care unit admission (p = 0.12) were comparable between the progesterone and placebo groups, but lower in these groups compared neonates of women in the control group (p < 0.001 respectively). Conclusion Maintenance treatment with progesterone gel and placebo were equally effective in preventing preterm birth among women with preterm labor. Both progesterone and placebo prolonged pregnancy more effectively than intravenous tocolysis alone. We hypothesize, that the acidic gel base reinforced the biochemical barrier at the uterine cervix, which counteracted ascending pathogen invasion and subsequent inflammation and thereby delayed preterm birth. The present results suggest, that non-hormonal agents that reinforce the biochemical cervical barrier can be useful for the prevention of preterm birth in clinical practice.

scholarly journals Maintenance treatment with progesterone gel and the gel base delayed preterm birth more effectively than intravenous tocolysis alone – a randomized controlled trial

2021 ◽  
Author(s):  
Ylva Vladic Stjernholm ◽  
Giovanna Marchini ◽  
Tomislav Vladic
Keyword(s):  
Intensive Care Unit ◽  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Preterm Labor ◽  
Neonatal Intensive Care ◽  
Maintenance Treatment ◽  
Controlled Trial ◽  
Neonatal Morbidity ◽  
Pathogen Invasion ◽  
Randomized Controlled

Abstract Introduction The aim was to evaluate the effect of maintenance treatment with progesterone gel compared to the gel base in delaying preterm birth among women with spontaneous preterm labor. Materials and Methods A randomized controlled trial in Sweden in 2009 − 18. Women with spontaneous preterm labor were randomized to daily progesterone gel 90 mg (n = 29) or gel base doses (n = 29) after intravenous tocolysis. Results The latency to delivery was 58 ± 34 days with progesterone gel and 64 ± 51 days with gel base (p = 0.83), compared to 2 days after intravenous tocolysis alone (both p < 0.001). The rate of preterm birth before 34 weeks was 34 % after progesterone gel and 38 % after gel base (p = 0.34). The composite neonatal morbidity (p = 0.65) and neonatal intensive care unit admission (p = 0.12) did not differ between the groups. Conclusion Preterm birth was delayed more effectively after both progesterone and gel base compared to intravenous tocoylsis alone, suggesting an effect of the gel base. We conclude, that the acidic gel base reinforced the physiological barrier at the uterine cervix, which counteracted ascending pathogen invasion and thereby delayed preterm birth.

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.

scholarly journals The effect of zinc supplementation on pregnancy outcomes: a double-blind, randomised controlled trial, Egypt

2015 ◽  
Vol 114 (2) ◽  
pp. 274-285 ◽  
Author(s):  
Samia A. Nossier ◽  
Noha E. Naeim ◽  
Nawal A. El-Sayed ◽  
Azza A. Abu Zeid
Keyword(s):  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Pregnancy Outcomes ◽  
Controlled Trial ◽  
Neonatal Morbidity ◽  
Control Group ◽  
Double Blind ◽  
Serum Zn ◽  
Randomised Controlled ◽  
Low Serum

The present randomised controlled trial (RCT) was conducted to evaluate the effect of two regimens of Zn supplementation on pregnancy outcomes in Alexandria, Egypt. Healthy pregnant women aged 20–45 years and having low serum Zn level below the estimated median for the gestational age were eligible to participate in the trial. Of 1055 pregnant women assessed for the eligibility of low serum Zn level, 675 were eligible. These women were randomly assigned to one of the three groups: the Zn alone group (n 225) received a daily dose of 30 mg ZnSO4, the combined group (n 227) received 30 mg ZnSO4 plus multivitamins (B1, B6, D3, C and E) and the control group (n 223) received placebo (270 mg lactose). They were followed up from the time of recruitment till 1 week after delivery. Overall, there was no detectable difference in the mean birth weight between the three groups (mean 2929·12 (sd 330·28), 2922·22 (sd 324·05) and 2938·48 (sd 317·39) g for the placebo, Zn and Zn plus multivitamin groups, respectively, P= 0·88). Both the single and the combined Zn supplements were almost equally effective in reducing second- and third-stage complications (relative risk (RR) 0·43, 95 % CI 0·31, 0·60 for the Zn group and RR 0·54, 95 % CI 0·40, 0·73 for the combined group). Stillbirth and preterm delivery were significantly lower among the two supplemented groups than the placebo group (P= 0·001). Early neonatal morbidity was also significantly lower in the supplemented groups (RR 0·23, 95 % CI 0·15, 0·35 for the Zn group and RR 0·25, 95 % CI 0·16, 0·37 for the combined group). Collectively, Zn supplementation was effective in reducing pregnancy complications and early neonatal infection among the Zn-deficient women of the present trial.

Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

2018 ◽  
Vol 3 (07) ◽  
Author(s):  
Ms. Sonam Yangchen Bhutia ◽  
Dr. Sushma Kumari Saini ◽  
Dr. Manmeet Kaur ◽  
Dr. Sandhya Ghai
Keyword(s):  
School Children ◽  
Home Visit ◽  
Controlled Trial ◽  
Family Members ◽  
Sampling Technique ◽  
Control Group ◽  
Food Hygiene ◽  
Parent Communication ◽  
Post Test ◽  
Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members.  After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

scholarly journals Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  
Keyword(s):  
Live Birth ◽  
Financial Support ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Fertility Treatment ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Operative Hysteroscopy ◽  
Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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