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

NCT03781466 | Unknown DMC

• 1 other identifier: aswu/190/18
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Twin; Pregnancy, Affecting Fetus or Newborn

Keywords

Preterm birth; Twin gestation; Vaginal progesterone; cervical cerclage

Outcome Measures

Primary Outcomes (1)

• Preterm labor before 34 weeks

  Number of patients with preterm birth before 34 weeks gestations

  Up to 34 weeks gestational age

Secondary Outcomes (2)

• Neonatal respiratory distress syndrome

  At birth

• Early neonatal death

  within one month postpartum

Study Arms (3)

Cervical cerclage

ACTIVE COMPARATOR

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

Procedure: Cervical cerclage

vaginal progesterone

ACTIVE COMPARATOR

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

Drug: vaginal progesterone

Cervical cerclage plus vaginal progesterone

ACTIVE COMPARATOR

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

Procedure: Cervical cerclage; Drug: vaginal progesterone

Interventions

Cervical cerclage PROCEDURE

Cervical cerclage indicated by short cervix ≤25mm

Also known as: Active Comparator

Cervical cerclage; Cervical cerclage plus vaginal progesterone

vaginal progesterone DRUG

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

Also known as: Active Comparator

Cervical cerclage plus vaginal progesterone; vaginal progesterone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women pregnant in dichorionic twins
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam, md

CONTACT

01022336052; hany.farouk@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A randomized clinical trial open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized clinical trial

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: March 1, 2021
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

EG (1)