Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-03-01

Brief Summary

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The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

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Detailed Description

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There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Conditions

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Twin; Pregnancy, Affecting Fetus or Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

A randomized clinical trial open label

Study Groups

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Cervical cerclage

Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm

Group Type ACTIVE_COMPARATOR

Cervical cerclage

Intervention Type PROCEDURE

Cervical cerclage indicated by short cervix ≤25mm

vaginal progesterone

Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks

Group Type ACTIVE_COMPARATOR

vaginal progesterone

Intervention Type DRUG

Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Cervical cerclage plus vaginal progesterone

Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks

Group Type ACTIVE_COMPARATOR

Cervical cerclage

Intervention Type PROCEDURE

Cervical cerclage indicated by short cervix ≤25mm

vaginal progesterone

Intervention Type DRUG

Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Interventions

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Cervical cerclage

Cervical cerclage indicated by short cervix ≤25mm

Intervention Type PROCEDURE

vaginal progesterone

Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Intervention Type DRUG

Other Intervention Names

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Active Comparator Active Comparator

Eligibility Criteria

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Inclusion Criteria

* Women pregnant in dichorionic twins.
* Transvaginal sonographic cervical length is \<25 mm at 16-20 weeks gestational age.
* No symptoms, signs or other risk factors for preterm labor

Exclusion Criteria

* Age \< 18 years or \> 45 years.
* Known allergy or contraindication (relative or absolute) to progesterone therapy.
* Monochorionic twins.
* Known major fetal structural or chromosomal abnormality.
* Intrauterine death of one fetus or death of both fetuses.
* Fetal reduction in the current pregnancy.
* Medical conditions that may lead to preterm delivery.
* Rupture of membranes.
* Vaginal bleeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No