Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in twin gestations: a systematic review and meta-analysis

Conde-Agudelo, Agustín; Romero, Roberto; Rehal, Anoop; Brizot, Maria de Lourdes; Serra, Vicente; Fonseca, Eduardo Borges da; Çetingöz, Elçin; Syngelaki, Argyro; Perales, Alfredo; Hassan, Sonia S.; Nicolaides, Kypros H.

doi:10.1016/j.ajog.2023.05.010

Cited by 15 publications

(4 citation statements)

References 77 publications

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“…Administration of vaginal progesterone to asymptomatic women with a twin gestation and a short cervix on ultrasonography in the second trimester reduced the risk of PTD when a dose of 400 mg, but not lower doses, was given. 30 , 31 This observation is consistent with our findings. On the contrary, other studies that evaluated the effect of progesterone to prevent PTD in unselected populations of twin pregnancies 32 , 33 and women with twins and a prior singleton SPTD 34 did not show benefit.…”

Section: Discussionsupporting

confidence: 93%

“…Although the number of twins in this study was small, to our knowledge, it is larger than in previous studies that evaluated the effect of progesterone to prolong pregnancy after APTL. Administration of vaginal progesterone to asymptomatic women with a twin gestation and a short cervix on ultrasonography in the second trimester reduced the risk of PTD when a dose of 400 mg, but not lower doses, was given . This observation is consistent with our findings.…”

Section: Discussionsupporting

confidence: 91%

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Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor

Nachum,

Ganor Paz,

Massalha

et al. 2024

JAMA Netw Open

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ImportanceWomen with arrested preterm labor (APTL) are at very high risk for spontaneous preterm delivery (SPTD), the leading cause of neonatal mortality and morbidity. To date, no maintenance therapy has been found to be effective for pregnancy prolongation. A few clinical trials with considerable methodological limitations have demonstrated some efficacy for 400 mg vaginal micronized progesterone (VMP) in women with APTL.ObjectiveTo investigate the effectiveness of daily 400 mg VMP for the prolongation of pregnancy after APTL.Design, Setting, and ParticipantsThis randomized clinical trial was conducted between December 19, 2018, and February 27, 2023, in 3 university-affiliated medical centers in Israel. Participants included women with singleton and twin pregnancies after APTL following tocolysis at 24 weeks 0 days to 34 weeks 0 days’ gestation. Women with a history of preterm delivery or asymptomatic cervical shortening in the current pregnancy were excluded.InterventionsParticipants were randomly allocated to receive VMP 200 mg twice a day or no treatment until 36 weeks 6 days’ gestation.Main Outcomes and MeasuresThe primary end points were mean number of days from study enrollment to delivery and the rate of SPTD prior to 37 weeks’ gestation.ResultsA total of 129 participants were enrolled (65 in the VMP group and 64 in the no-treatment group). Mean (SD) age was 27.6 (5.1) years. Between the VMP and no-treatment groups, there was no difference in pregnancy prolongation (mean [SD], 40.0 [17.8] vs 37.4 [20.3] days; P = .44) and the rate of SPTD (16 [25%] vs 19 [30%]; relative risk, 0.8; 95% CI, 0.5-1.5; P = .52). In twin pregnancies, including 12 and 15 pairs in the VMP and no-treatment groups, respectively, VMP prolonged pregnancy (mean [SD], 43.7 [18.1] vs 26.1 [15.2] days; P = .02), postponed the delivery week (36.5 [1.4] vs 34.7 [2.2] weeks; P = .01), shortened the length of stay in the neonatal intensive care unit (4.9 [10.6] vs 13.2 [18.5] days; P = .03) and overall hospital stay (8.3 [9.6] vs 15.1 [17.2] days; P = .03), and was associated with a higher birth weight (2444 [528] vs 2018 [430] g; P = .01).Conclusions and RelevanceThese findings show that VMP given in a dosage of 200 mg twice a day following APTL is not an effective treatment to prolong pregnancy or prevent SPTD. However, VMP demonstrated beneficial effects in twin pregnancies, warranting further investigation.Trial RegistrationClinicalTrials.gov Identifier: NCT02430233

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 91%

Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor

Nachum,

Ganor Paz,

Massalha

et al. 2024

JAMA Netw Open

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“…These are all highly beneficial outcomes for maternal and infant health. Conde-Agudelo et al (28) evaluated the efficacy of vaginal progesterone in preventing premature delivery and adverse perinatal outcome of twin pregnancy. The results showed that vaginal progesterone could not prevent premature delivery or improve the perinatal outcome of unselected twin pregnancy, but it seemed to reduce the risk of premature delivery in early gestational age and the morbidity and mortality of twins with short cervical ultrasound examination.…”

Section: Discussionmentioning

confidence: 99%

Effects of vaginal progesterone and placebo on preterm birth and antenatal outcomes in women with singleton pregnancies and short cervix on ultrasound: a meta-analysis

Peng,

Gao,

Yuan

et al. 2024

Front. Med.

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BackgroundVaginal progesterone in preterm birth and adverse outcomes caused by cervical insufficiency remains controversial. To address it, the effect of vaginal progesterone on preterm delivery and perinatal outcome of single pregnancy women with short cervix (less than 25 mm) was systematically evaluated by meta-analysis.Methods“Vaginal progesterone,” “placebo,” “ultrasound,” “cervix,” “singleton pregnancy,” “preterm birth,” and “antenatal outcomes” were entered to screen clinical studies PubMed, Embase, and the Chinese Biomedical Literature Database (CBM). The study population consisted of women with singleton pregnancies and a short cervix on ultrasound, and were assigned into the progesterone group (n = 1,368) and the placebo group (n = 1,373). Treatment began after the patient was diagnosed with short cervix until delivery. Neonatal survival rate, Neonatal Intensive Care Unit (NICU) admission rate, respiratory distress syndrome (RDS), intraventricular hemorrhage (IVH), neonatal mortality, and birth weight <1,500 g were analyzed.ResultsA total of 8 articles, totaling 2,741 study subjects, were enrolled. The progesterone group exhibited an obvious reduced rate of preterm birth at <34 weeks (OR = 0.67, 95% CI: 0.53∼0.84; Z = 3.53, P = 0.004), preterm birth at <32 weeks (OR = 0.46, 95% CI: 0.28∼0.77; Z = 2.99, P = 0.003), NICU admission rate (OR = 0.45, 95% CI: 0.30∼0.66; Z = 0.15, P < 0.0001), RDS rate (OR = 0.42, 95% CI: 0.28∼0.63; Z = 4.25, P < 0.0001), IVH incidence rate (OR = 0.40, 95% CI: 0.17∼0.95; Z = 2.08, P = 0.04), neonatal mortality (OR = 0.25, 95% CI: 0.13∼0.46; Z = 4.39, P < 0.0001), and proportion of neonates with birth weight < 1,500 g (OR = 0.45, 95% CI: 0.32∼0.64; Z = 4.50, P < 0.0001).ConclusionVaginal progesterone lowered the incidences of preterm birth and adverse pregnancy outcomes in women with singleton pregnancies and a short cervix.

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“… 4 According to a systematic review and meta-analysis, vaginal progesterone cannot prevent preterm birth in uncomplicated twin pregnancies; however, in twin pregnancies with a short cervix (<25 mm), it could decrease preterm birth at early gestational age. 17 In addition, another systematic review and meta-analysis showed that in twin pregnancies, cervical cerclage could reduce preterm birth rate in cervical length <15 mm. 18 Cervical pessary is a less invasive surgical approach that theoretically provides mechanical support for the cervix, and different studies have reported heterogeneous results on its efficacy.…”

Section: Introductionmentioning

confidence: 99%

The effect of cervical pessary on increasing gestational age at delivery in twin pregnancies with asymptomatic short cervix: a systematic review and meta-analysis of randomized controlled trials

Norooznezhad,

Zargarzadeh,

Javinani

et al. 2024

AJOG Global Reports

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Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in twin gestations: a systematic review and meta-analysis

Cited by 15 publications

References 77 publications

Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor

Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor

Effects of vaginal progesterone and placebo on preterm birth and antenatal outcomes in women with singleton pregnancies and short cervix on ultrasound: a meta-analysis

The effect of cervical pessary on increasing gestational age at delivery in twin pregnancies with asymptomatic short cervix: a systematic review and meta-analysis of randomized controlled trials

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