The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage

Siew, Jia Yun S.; Allen, John C.; Hui, Celene Yy; Ku, Chee Wai; Malhotra, Rahul; Østbye, Truls; Tan, Thiam Chye

doi:10.1016/j.ejogrb.2018.07.028

Cited by 35 publications

(32 citation statements)

References 16 publications

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“…As far as we know, most studies suggested that serum progesterone levels were associated with pregnancy outcome, especially in the first trimester. Serum progesterone in abortion patients was generally lower than that in continuing pregnancy [10][11][12][13][14]. In our study, a negative correlation between serum progesterone and early pregnancy failure was further described.…”

Section: Discussionsupporting

confidence: 60%

“…Covariates. The selection of covariates in this study was mainly based on previous studies which researched the relationship between progesterone and pregnancy outcome [10][11][12][13][14][17][18][19][20][21][22]. Therefore, patients' basic demographics (age, height, weight, smoking history, drinking history, and marital status), obstetric history (times of gestity, parity, and abortion), and clinical information (gestational week, progesterone, β-HCG, medical history, and use of progesterone) were collected.…”

Section: 4mentioning

confidence: 99%

“…Several studies showed that low serum progesterone was associated with abortion [10][11][12][13][14]. Hence, exogenous progesterone supplements were often used to treat threatened abortion, especially in China [15].…”

Section: Introductionmentioning

confidence: 99%

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Baseline Levels of Serum Progesterone and the First Trimester Pregnancy Outcome in Women with Threatened Abortion: A Retrospective Cohort Study

Deng

Chen

et al. 2020

BioMed Research International

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Objective. The relationship between serum progesterone and the first trimester pregnancy outcome of threatened abortion is still controversial. Therefore, we aimed to further study the association between these two parameters. Methods. The present study is an observational retrospective cohort study. A total of 726 participants who had threatened abortion from a hospital in Guangdong, China, were included in this study from 17th August 2011 to 30th October 2018. The exposure variable and the outcome variable were serum progesterone measured at baseline and early pregnancy outcome, respectively. Covariates involved in this study included patients' basic demographics, obstetric history, and clinical information. Results. A negative association and a saturation effect were detected between serum progesterone and the first trimester pregnancy outcome. When progesterone <90.62 nmol/L, an increase in 1 nmol/L of serum progesterone was associated with 3% decrease of the risk of miscarriage (OR: 0.97, 95% CI: 0.95-0.98). Conclusion. There was a greater risk of abortion when the serum progesterone level was less than 90.62 nmol/L. Our findings can better assist the clinician in understanding patients' conditions and making medical decisions.

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Section: Discussionsupporting

confidence: 60%

Section: 4mentioning

confidence: 99%

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Baseline Levels of Serum Progesterone and the First Trimester Pregnancy Outcome in Women with Threatened Abortion: A Retrospective Cohort Study

Deng

Chen

et al. 2020

BioMed Research International

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“…In a trial by Vincze et al 24 , miscarriage occurred in 8.1 and 7.9% of women receiving oral dydrogesterone and vaginal progesterone, respectively. In the trial by Siew et al, 25 miscarriage occurred in 15.3 and 10.2% in women receiving dihydroprogesterone and micronised progesterone, respectively. There are several explanations for the differences in benefits of live birth and miscarriage observed between oral progestogen and vaginal progesterone.…”

Section: Oral Progestogen Versus Vaginal Progesteronementioning

confidence: 96%

“…To date, three small RCTs [23][24][25] directly comparing the use of oral progestogen and vaginal progesterone for the prevention of miscarriage in women with threatened miscarriage were underpowered to detect statistical significance for the estimated effect size. In one RCT by Czajkowski et al, 23 miscarriage occurred in 8.3 and 13.8% of women in the oral dydrogesterone and vaginal progesterone groups, respectively.…”

Section: Oral Progestogen Versus Vaginal Progesteronementioning

confidence: 99%

Effect of progestogen for women with threatened miscarriage: a systematic review and meta‐analysis

Zhang

Tan

et al. 2020

BJOG

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Progestogen for treating threatened miscarriage

Wahabi

Fayed

Esmaeil

et al. 2018

Cochrane Database of Systematic Reviews

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of findings for the main comparison. Progesterone compared to placebo or no treatment for treating threatened miscarriage Progesterone compared to placebo or no treatment for treating threatened miscarriage Patient or population: women with threatened miscarriage Setting: two in high-income countries (Germany and Italy), four in upper-middle income countries (two in Iran, one in Malaysia and one in Turkey) and one in lower-income country (Jordan). All in hospitals (university or women's) or medical centres Intervention: progesterone Comparison: placebo or no treatment Anticipated absolute effects * (95% CI) Outcomes Risk with placebo or no treatment Risk with progesterone Relative effect (95% CI) № of participants (trials) Certainty of the evidence (GRADE) Comments Study population Miscarriage 242 per 1000 138 per 1000 (102 to 189) RR 0.64 (0.47 to 0.87) 696 (7 RCTs) ⊕⊕⊕⊝ Moderate 1 Study population Preterm birth 91 per 1000 84 per 1000 (49 to 142) RR 0.86 (0.52 to 1.44) 588 (5 RCTs) ⊕⊕⊝⊝ Low 1, 2 Study population Congential abnormalities 13 per 1000 9 per 1000 (1 to 62) RR 0.70 (0.10 to 4.82) 337 (2 RCTs) ⊕⊝⊝⊝ Very low 1, 2, 3 *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.

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The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage

Cited by 35 publications

References 16 publications

Baseline Levels of Serum Progesterone and the First Trimester Pregnancy Outcome in Women with Threatened Abortion: A Retrospective Cohort Study

Baseline Levels of Serum Progesterone and the First Trimester Pregnancy Outcome in Women with Threatened Abortion: A Retrospective Cohort Study

Effect of progestogen for women with threatened miscarriage: a systematic review and meta‐analysis

Progestogen for treating threatened miscarriage

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