Making miscarriage matter

Chong, Krystle Y.; Li, Wentao; Roberts, Ian; Mol, Ben Willem J.

doi:10.1016/s0140-6736(21)01379-9

Cited by 6 publications

(7 citation statements)

References 6 publications

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“…This Cochrane review had already excluded a large study that had been retracted following concerns about the accuracy and trustworthiness of the trial data ( Ismail et al , 2018 ). We previously expressed concern on other three trials that were included in the 2019 Cochrane review ( Chong et al , 2021 ). Without these three studies, the treatment effect of progesterone becomes minimal and non-significant (RR 0.95, 95% CI 0.79–1.13).…”

Section: Discussionmentioning

confidence: 99%

Progesterone for women with threatened miscarriage (STOP trial): a placebo-controlled randomized clinical trial

et al. 2023

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STUDY QUESTION In women with threatened miscarriage, does progesterone supplementation until the completion of the first trimester of pregnancy increase the probability of live birth? SUMMARY ANSWER In women with threatened miscarriage, 400 mg vaginal progesterone nightly, from onset of bleeding until 12 weeks, did not increase live birth rates. WHAT IS KNOWN ALREADY Limited evidence has indicated that vaginal micronized progesterone may make little or no difference to the live birth rate when compared with placebo in women with threatened miscarriage. Subgroup analysis of one recent randomized trial reported that in women with bleeding and at least one previous miscarriage, progesterone might be of benefit. STUDY DESIGN, SIZE, DURATION We performed a randomized, double-blinded, placebo-controlled trial between February 2012 and April 2019. Eligible pregnant women under 10 weeks gestation, experiencing a threatened miscarriage as apparent from vaginal bleeding were randomized into two groups in a 1:1 ratio: the intervention group received 400 mg progesterone as vaginal pessaries, the control group received placebo vaginal pessaries, both until 12 weeks gestation. The primary endpoint was live birth. We planned to randomize 386 women (193 per group). The study was stopped at a planned interim analysis for futility after randomization of 278 women. PARTICIPANTS/MATERIALS, SETTING, METHODS This trial was conducted at the Mater Mothers’ Hospital, a tertiary centre for maternity care in South Brisbane, Queensland, Australia. We randomized 139 women to the intervention group and 139 women to the placebo group. Primary outcome data were available for 136 women in the intervention group and 133 women in the placebo group. MAIN RESULTS AND THE ROLE OF CHANCE The live birth rates were 82.4% (112/136) and 84.2% (112/133) in the intervention group and placebo group, respectively (risk ratio (RR) 0.98, 95% CI 0.88 to 1.09; risk difference −0.02, 95% CI −0.11 to 0.07; P = 0.683). Among women with at least one previous miscarriage, live birth rates were 80.6% (54/67) and 84.4% (65/77) (RR 0.95, 95% CI 0.82–1.11; P = 0.550). No significant effect was seen from progesterone in women with two (RR 1.28, 95% CI 0.96–1.72; P = 0.096) or more (RR 0.79, 95% CI 0.53–1.19; P = 0.267) previous miscarriages. Preterm birth rates were 12.9% and 9.3%, respectively (RR 1.38; 95% CI 0.69 to 2.78; P = 0.361). Median birth weight was 3310 vs 3300 g (P = 0.992). There were also no other significant differences in obstetric and perinatal outcomes. LIMITATIONS, REASONS FOR CAUTION Our study was single centre and did not reach the planned sample size because it was stopped prematurely at an interim analysis. WIDER IMPLICATIONS OF THE FINDINGS We did not find evidence supporting the treatment effect of vaginal progesterone in women with threatened miscarriage. Progesterone in this setting should not be routinely used for threatened miscarriage. The treatment effect in women with threatened miscarriage after previous miscarriages warrants further research. STUDY FUNDING/COMPETING INTEREST(S) Mothers’ and babies Golden Casket Clinical Fellowship (L.A.M.). Progesterone and placebo pessaries were provided by Perrigo Australia. B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. TRIAL REGISTRATION NUMBER ACTRN12611000405910 TRIAL REGISTRATION DATE 19 April 2011 DATE OF FIRST PATIENT’S ENROLMENT 06 February 2012

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Section: Discussionmentioning

confidence: 99%

Progesterone for women with threatened miscarriage (STOP trial): a placebo-controlled randomized clinical trial

et al. 2023

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“…Study indicated a significant association between each 10unit increase in SO2 and spontaneous miscarriage in lag 0 and 9 days. Chong et al [1] also opined that pregnant women should avoid polluted air. Desai did a study to know the impact of miscarriage under reporting on pregnancy data and related research.…”

Section: Discussionmentioning

confidence: 99%

“…Miscarriage, defined as the loss of a pregnancy before viability, occurring in more than 10% of women affecting woman's overall health, is one of the most prevalent negative reproductive outcomes around the world [1]. Knowing occurrence, causes and prevention of recurrence are great persisting challenges.…”

Section: Introductionmentioning

confidence: 99%

Community Based Prospective Study of Miscarriages in Context of Biomass Fuel use by Tribal Women of Rural Remote Region

Chhabra¹

2022

OAJG

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Background: Miscarriage is one of most prevalent negative reproductive outcomes which affects women’s health globally. Knowing occurrence, causes, prevention of recurrence are great challenges. Exposure to air pollutant may be responsible for higher risk of miscarriage. Objective: Community based prospective study was carried out to know about the occurrence of miscarriages in context of Biomass fuel use by rural tribal, pregnant women. Setting: Villages and Dr. Sushila Nayar Hospital, Utavali, Melghat, Amravati Maharashtra. Methods: After approval of the institute’s ethics committee, study was conducted in 100 villages. After base information, villages were divided into 50 study, 50 controls, subdivided into 40 study villages with advocacy for protection from ill effects of Biomass fuel, 40 non-advocacy controls and 10 study villages where in addition to advocacy Chimneys were fixed on roofs of huts with no windows, for exit of smoke and 10 controls where neither advocacy was done nor Chimneys were fixed. Main Outcome Measures: Change in occurrence of miscarriage with Biomass fuel use. Results: In 50 study villages, of 1005 pregnancies, 2.8% reported miscarriages and in 50 controls, of 1097 pregnancies 3.1% had miscarriage. Of 2700 pregnancies in 40 Advocacy study villages 6.6%, of 40 controls of 2700 pregnancies, 10.5% had miscarriages. In 10 villages with Advocacy as well as Chimneys, of 700 pregnancies, 2.4% had miscarriages in 10 controls, of 700 pregnancies 5.6% ended in miscarriages. In first year it could have been underreporting. Conclusion: In rural tribal women miscarriages were not more than globally known, but Biomass fuel did affect occurrence of miscarriages.

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“…Notably, one of the analyzed trials within the review has since been retracted 51 . Further concerns have emerged over other studies incorporated in the analysis 52 . In response, Cochrane conducted another meta-analysis in 2021, including 7 randomized trials with a total cohort of 5682 women.…”

Section: Critical Studies On Progesterone Supplementationmentioning

confidence: 99%

Luteal Phase Defects and Progesterone Supplementation

Collins,

Gatta,

Dotters-Katz

et al. 2024

Obstetrical &Amp; Gynecological Survey

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Importance Luteal phase defects (LPDs), or an insufficiency of progesterone production during the luteal phase of the menstrual cycle, have been identified as a potential cause of recurrent pregnancy loss (RPL), but its exact contribution to RPL is not well-defined. In addition, the role of exogenous progesterone supplementation during pregnancy remains controversial. Objective The goal of this review is to provide an updated, evidence-based summary of LPD, including prevalence and potential pathophysiologic mechanisms, and to explore the current controversies regarding progesterone supplementation for management and treatment of RPL. Evidence Acquisition A literature review identified relevant research using a PubMed search, Cochrane summaries, review articles, textbook chapters, databases, and society guidelines. Results Endogenous progesterone plays a crucial role in the first trimester of pregnancy, and therefore, insufficiency may contribute to RPL. However, the precise relationship between LPD and RPL remains unclear. Luteal phase defect is primarily a clinical diagnosis based on a luteal phase less than 10 days. Although there may be a possibility of incorporating a combined clinical and biochemical approach in defining LPD, the current lack of validated diagnostic criteria creates a challenge for its routine incorporation in the workup of infertility. Moreover, no treatment modality has demonstrated efficacy in improving fertility outcomes for LPD patients, including progesterone supplementation, whose inconsistent data do not sufficiently support its routine use, despite its minimal risk. It is imperative that women diagnosed with LPD should be worked up for other potential conditions that may contribute to a shortened luteal phase. Future work needs to focus on identifying a reproducible diagnostic test for LPD to guide treatment. Conclusions and Relevance Currently, the perceived relationship between LPD and RPL is challenged by conflicting data. Therefore, patients with an abnormal luteal phase should undergo a thorough workup to address any other potential etiologies. Although supplemental progesterone is commonly utilized for treatment of LPD and RPL, inconsistent supporting data call for exogenous hormone therapy to be only used in a research setting or after a thorough discussion of its shortcomings. Target Audience Obstetricians and gynecologists, family physicians Learning Objectives After completing this activity, the learner will be better able to explain the various definitions, diagnostic criteria, and potential pathophysiologic mechanisms of LPD; discuss the current controversies surrounding the role of LPD within RPL; and delineate the current studies and recommendations for treatment, specifically the use of progesterone supplementation.

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Making miscarriage matter

Abstract: increasing burden in HIV among Black and Latinx Americans in southern USA was substantially driven by persistent social and structural determinants that must be addressed to improve health outcomes and the broader goal of human wellbeing and flourishing.

Cited by 6 publications

References 6 publications

Progesterone for women with threatened miscarriage (STOP trial): a placebo-controlled randomized clinical trial

Progesterone for women with threatened miscarriage (STOP trial): a placebo-controlled randomized clinical trial

Community Based Prospective Study of Miscarriages in Context of Biomass Fuel use by Tribal Women of Rural Remote Region

Luteal Phase Defects and Progesterone Supplementation

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