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

Not Applicable

• Conditions: Twin; Pregnancy, Affecting Fetus or Newborn
• Interventions: Procedure: Cervical cerclage; Drug: vaginal progesterone

• Registration Number: NCT03781466
• Lead Sponsor: Aswan University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Study Start: 2019-01-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Preterm labor before 34 weeks	Up to 34 weeks gestational age	Number of patients with preterm birth before 34 weeks gestations

Secondary Outcome Measures

Name	Time	Method
Neonatal respiratory distress syndrome	At birth	number of neonatal respiratory distress syndrome
Early neonatal death	within one month postpartum	number babies died in the neonatal period

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt