Vaginal progesterone is as effective as cervical cerclage to prevent preterm birth in women with a singleton gestation, previous spontaneous preterm birth, and a short cervix: updated indirect comparison meta-analysis

Conde-Agudelo, Agustín; Romero, Roberto; Fonseca, Eduardo Borges da; O’Brien, John; Çetingöz, Elçin; Creasy, George W.; Hassan, Sonia S.; Erez, Offer; Pacora, Percy; Nicolaides, Kypros H.

doi:10.1016/j.ajog.2018.03.028

Cited by 128 publications

(68 citation statements)

References 147 publications

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“…In a meta-analysis of four randomized trials in which singleton pregnancies were screened with cervical ultrasound examination and randomly assigned to cerclage or no cerclage if the cervix was short, cerclage placement in women with no prior preterm birth did not result in significant reduction in birth <35 weeks (21% vs 31% without cerclage: relative risk 0.84, 95% CI 0.60-1.17) [42]. In women with a short cervix (≤25 mm) at midtrimester, singleton gestation and prior preterm birth earlier than 34 weeks, cerclage and vaginal progesterone are equally effective in an indirect comparison meta-analysis for preventing preterm birth and improving perinatal outcomes [43]. However, the choice of treatment should depend on the risk of adverse events and cost-effectiveness of interventions, and patient/physician's preferences.…”

Section: Prevention Of Spontaneous Preterm Birthmentioning

confidence: 99%

The first-trimester of pregnancy – A window of opportunity for prediction and prevention of pregnancy complications and future life

Poon

McIntyre

Hyett

et al. 2018

Diabetes Research and Clinical Practice

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The International Federation of Gynecology and Obstetrics (FIGO) has identified non communicable maternal diseases (NCDs) as a new focus area. NCDs and exposures as related to pregnancy complications and later impairment of maternal and offspring health will form the basis for action in the forthcoming years. This paper summarizes recent advances, centered on the use of first-trimester testing, as a window of opportunity to predict and prevent many pregnancy complications; and for potential future prevention of NCDs in mother and offspring. Recent results from a large-scale randomized control trial have provided definitive proof that effective screening for preterm preeclampsia (preterm-PE), requiring delivery before 37 weeks' gestation, can be achieved with a combined test of maternal factors and biomarkers at 11-13 weeks and that aspirin, given to high-risk women, is effective in reducing the risk of preterm-PE and the length of stay in neonatal intensive care unit. This is the first successful example to illustrate that pregnancy complications is predictable and preventable in early pregnancy. Similar prediction and prevention strategies are being developed for hyperglycemia in pregnancy and preterm birth, with the intention for longer lasting interventions leading to significant downstream impact in improving long-term health in both mothers and babies.

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Section: Prevention Of Spontaneous Preterm Birthmentioning

confidence: 99%

The first-trimester of pregnancy – A window of opportunity for prediction and prevention of pregnancy complications and future life

Poon

McIntyre

Hyett

et al. 2018

Diabetes Research and Clinical Practice

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“…On the basis of available evidence of progesterone treatment in women with asymptomatic short cervix [12], women in the assigned group will be unblinded if the TVCL measurement is ≤ 25 mm. The women receiving placebo will be given the option of oral progesterone (10 mg three times per day) or vaginal progesterone 200 mg daily (Endometrin, Ferring Pharmaceuticals Inc., Parsippany, NJ, USA; or Utrogestan, Besins Healthcare, Monaco) until 36+ weeks of gestation (or cervical cerclage if the women has a history of preterm delivery or second-trimester miscarriage) [20]. For women in the progesterone group whose cervical length is ≤ 25 mm at 18 + 0 to 23 + 6 weeks of gestation, options will be offered of continuation of oral progesterone (10 mg three times per day), vaginal progesterone 200 mg daily (Endometrin or Utrogestan), or cervical cerclage if the women have a history of PTB.…”

Section: Methodsmentioning

confidence: 99%

Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial

Cheung

Seto

2020

Trials

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Background: Preterm birth accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. For a singleton pregnancy, progesterone treatment is effective in prevention of preterm birth in women with an asymptomatic short cervix or a history of preterm birth. However, a large proportion of preterm births still is not currently preventable. The aim of this study is to determine whether early universal use of oral progesterone before 14 + 0 weeks of gestation can prevent preterm birth better than universal screening of cervical length at 18 + 0 to 23 + 6 weeks of gestation, followed by progesterone treatment in those with a short cervix in singleton pregnancy.Methods: This is a multicenter, randomized, double-blind, placebo-controlled trial registered with ClinicalTrials.gov on 12 February 2018. Eligible consecutive pregnant women with singleton gestation attending antenatal outpatient clinics will be recruited after receiving counseling and signing the written consent form. Transvaginal cervical length measurement will be performed at recruitment (before 14 + 0 weeks of gestation) and between 18 + 0 and 23 + 6 weeks of gestation. After randomization, women will be randomly assigned to either the treatment group (oral dydrogesterone 10 mg three times daily) or the placebo group, and medication will be started before 14 + 0 weeks of gestation. Assigned groups will be unblinded if the cervical length is ≤ 25 mm between 18 + 0 and 23 + 6 weeks of gestation, and the management option for short cervix will be discussed (oral progesterone, vaginal progesterone, or cervical cerclage). The primary outcome is preterm birth before 37 + 0 weeks of gestation.Discussion: Progesterone is used extensively in part of the in vitro fertilization program as luteal phase support, and it is not associated with teratogenicity. Universal progesterone supplementation may be a better approach to prevent preterm birth. This large, multicenter, randomized, double-blind, placebo-controlled trial will provide the best evidence, leading to the best strategy for the prevention of preterm birth.Trial registration: ClinicalTrials.gov, NCT03428685. Registered on 12 February 2018.

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“…3 Progesterone and/or cervical cerclage are recommended in women with such risk factors to reduce significantly their risk of PTB. 4,5 Therefore, midtrimester cervical length (CL) is recommended by several societies. [6][7][8][9] Universal screening of midtrimester short cervix could lead to a reduction of 18% of PTB, improvement of infants' quality of life, and major health care cost savings.…”

mentioning

confidence: 99%

Ultrasonographic Transabdominal Measurement of Uterine Cervical Length for the Prediction of a Midtrimester Short Cervix

et al. 2020

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Objective This study was aimed to estimate the value of transabdominal (TA) ultrasound measurement of cervical length (CL), as an alternative of transvaginal (TV) ultrasound, for universal screening of short cervix in the midtrimester. Study Design We conducted a prospective cohort study of nulliparous women with singleton pregnancy at 20 to 24 weeks of gestation. All participants underwent TA ultrasound followed by TV ultrasound with acquisitions of images and videos of the uterine cervix. A second sonographer, blinded to the participants' data and pregnancy outcomes, measured the CL using TA and TV images and videos. Pearson's correlation test and receiver operating characteristic (ROC) curve analyses were performed. Results A total of 805 participants were recruited, including 780 (97%) where TA CL measurement was feasible. We observed a strong correlation of CL between TA and TV (correlation coefficient: 0.57; p < 0.0001) with a mean TA measurement being 4 mm (95% confidence interval [CI]: −6 to 14 mm) below the mean TV measurement (mean of differences: 5 ± 4 mm). We observed that a TA CL <30 mm was highly predictive of a short cervix defined as a TV CL ≤25 mm (area under the ROC curve: 0.97; 95% CI: 0.95–0.99; p < 0.0001) with a sensitivity of 100% and a false-positive rate of 22%. Conclusion Universal short cervix screening in nulliparous women could be performed using TA ultrasound, which could allow the avoidance of TV ultrasound in more than three quarter of women. In low-risk population, TV ultrasound could be reserved to women with TA CL <30 mm. Key Points

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Vaginal progesterone is as effective as cervical cerclage to prevent preterm birth in women with a singleton gestation, previous spontaneous preterm birth, and a short cervix: updated indirect comparison meta-analysis

Cited by 128 publications

References 147 publications

The first-trimester of pregnancy – A window of opportunity for prediction and prevention of pregnancy complications and future life

The first-trimester of pregnancy – A window of opportunity for prediction and prevention of pregnancy complications and future life

Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial

Ultrasonographic Transabdominal Measurement of Uterine Cervical Length for the Prediction of a Midtrimester Short Cervix

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