Role of micronized progesterone in prevention of preterm labour in women with previous history of one or more preterm births: a research study at a tertiary care hospital

Ahuja, Rashmi; Sood, Anupa; Mittal, Rita

doi:10.18203/2320-1770.ijrcog20150450

Cited by 4 publications

(4 citation statements)

References 13 publications

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“…Seventeen potentially eligible trials were unavailable (without access to IPD we were unable to confirm eligibility or verify randomisation). [51][52][53][54][55][56][57][58][59][60][61][62][63][64][65][66][67] Three trials could not be traced, no response was obtained from eight and two declined to participate, data were no longer stored for four trials including three completed before 1985 Appendix Table 7). Together these 17 trials, which were mostly single-centre and unregistered, accounted for a relatively small proportion of data.…”

Section: Resultsmentioning

confidence: 99%

Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials

Stewart¹,

Simmonds

Duley³

et al. 2021

The Lancet

143

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BackgroundPreterm birth is a global health priority. Using a progestogen during high-risk pregnancy could reduce PTB and adverse neonatal outcomes. MethodsSystematic review of randomised trials comparing vaginal progesterone, intramuscular 17hydroxyprogesterone caproate (17-OHPC), or oral progesterone with control, or with each other, in asymptomatic women at risk of preterm birth. We identified published and unpublished trials that completed primary data collection before July 30, 2016 (12 months before data collection began) by searching MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers between inception and July 30, 2019. Trials of progestogen to prevent early miscarriage or immediately-threatened preterm birth were excluded. Individual participant data were requested from investigators of eligible trials. Outcomes included preterm birth, early preterm birth, and mid-trimester birth. Adverse neonatal sequelae associated with early births were assessed using a composite of serious neonatal complications, and individually. Adverse maternal outcomes were investigated as a composite and individually. Individual participant data were checked and risk of bias assessed independently by two researchers. Primary meta-analyses used one-stage generalised linear mixed models that incorporated random effects to allow for heterogeneity across trials. FindingsInitial searches identified 47 eligible trials. Individual participant data were available for 30 of these trials. An additional trial was later included in a targeted update. Data were therefore available from a total of 31 trials (11,644 women and 16,185 offspring). Trials in singleton pregnancies included mostly women with previous spontaneous preterm birth or short cervix. Preterm birth before 34 weeks was reduced in such women who received vaginal progesterone (nine trials, 769 women; relative risk [RR] 0•78, 95% CI 0•68-0•90), 17-OHPC (five trials, 3,053 women; 0•83, 0•68-1•01), and oral progesterone (two trials, 183 women; 0•60, 0•41-0•90). Results for other birth and neonatal outcomes were consistently favourable, but less certain. A possible increase in maternal complications was suggested, but this was uncertain. We identified no consistent evidence of treatment interaction with any participant characteristics examined, although analyses within subpopulations questioned efficacy in women who did not have a short cervix. Trials in multifetal pregnancies mostly included women without additional risk factors. For twins, vaginal progesterone did not reduce preterm birth before 34 weeks (eight trials, 2046 women: RR 1•01, 95% CI 0•84-1•20) nor did 17-OHPC for twins or triplets (eight trials, 2253 women: 1•04, 0•92-1•18). Preterm premature rupture of membranes was increased with 17-OHPC exposure in multifetal gestations (rupture <34 weeks RR 1•59, 95% CI 1•15-2•22), but we found no consistent evidence of benefit or harm for other outcomes with either vaginal progesterone or 17-OHPC InterpretationVaginal progesterone and 17...

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Section: Resultsmentioning

confidence: 99%

Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials

Stewart¹,

Simmonds

Duley³

et al. 2021

The Lancet

143

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“…Two trials did not reach their target sample size 16,17 ; four trials did not mention a sample size and power calculation and are probably underpowered. [18][19][20][21] When combined in an IPD meta-analysis, there is convincing evidence of the benefit of progesterone in these women. 22 To some extent, existing previous research decides how informative a trial can be.…”

Section: N For M Ation Ga I N: Is Th E Propose D St U Dy L a Rge A N ...mentioning

confidence: 99%

“…Many of these ‘trials’ individually fail to show any benefit. Two trials did not reach their target sample size 16,17 ; four trials did not mention a sample size and power calculation and are probably underpowered 18–21 . When combined in an IPD meta‐analysis, there is convincing evidence of the benefit of progesterone in these women 22 …”

Section: Information Gain: Is the Proposed Study Large And Long Enoug...mentioning

confidence: 99%

Assessing the usefulness of randomised trials in obstetrics and gynaecology

Hooft

Dijk

Axfors

et al. 2023

BJOG

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“…Spontaneous preterm labor (PTL) is one of the major causes of preterm birth (PTB), which accounts for 56% of the total PTB [1] and it possesses deteriorating effects, both long and short term, on the health of the mother and the offspring [2]. Moreover, statistics showed that 30% of pregnant women who experienced spontaneous PTL are often spontaneous with no known signs of PTL (herein termed as spontaneous unexplained PTL with intact membrane (sPTL-IM)) [3].…”

Section: Introductionmentioning

confidence: 99%

Spontaneous Unexplained Preterm Labor with Intact Membrane: Finding Protein Biomarkers through Placenta Proteome

Tan¹,

Daim²,

Jamil³

et al. 2018

Electrophoresis - Life Sciences Practical Applications

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Spontaneous unexplained preterm labor with intact membrane (sPTL-IM) remains as an unresolved challenge in obstetrics due to the complex syndromes involved during preterm birth. Two dimensional-gel electrophoresis (2D-GE) coupled with matrixassisted laser desorption/ionization-time of flight/time of flight (MALDI TOF/TOF) mass spectrometry has become an alternative in screening for potential novel protein-based biomarkers and revealing the pathophysiology of sPTL-IM. To achieve this objective, protein extracted from fetal and maternal sides of the placenta obtained from sPTL-IM (n = 5) and the respective control (n = 10) groups were separated and compared using 2D-gel electrophoresis. MALDI-TOF/TOF mass spectrometry was utilized to identify the differentially expressed proteins between both groups, and the molecular functions of these proteins were studied. A total of 12 proteins were significantly differentiated in sPTL-IM over the control. Differentially expressed proteins were identified to have involved in structural/cytoskeletal components, immune responses, fetal and placenta development, and anticoagulation cascade. More proteins were found to be differentially expressed in the fetal side compared to the maternal side of the placenta. This postulates that the influence of sPTL-IM from fetus is greater than that of the mother. Ultimately, these results might lead to further investigations in elucidating the potential of these proteins as biomarkers and/or drug targets.

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Role of micronized progesterone in prevention of preterm labour in women with previous history of one or more preterm births: a research study at a tertiary care hospital

Cited by 4 publications

References 13 publications

Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials

Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials

Assessing the usefulness of randomised trials in obstetrics and gynaecology

Spontaneous Unexplained Preterm Labor with Intact Membrane: Finding Protein Biomarkers through Placenta Proteome

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