NCT05334264

Brief Summary

This randomized controlled trial is aimed to assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

December 11, 2021

Last Update Submit

July 11, 2023

Conditions

Preterm BirthTwin Pregnancy, Antepartum Condition or ComplicationCervical Cerclage

Outcome Measures

Primary Outcomes (1)

  • The incidence of preterm birth at ≤35+6, ≤33+6, and ≤31+6 weeks.

    Number of preterm deliveries stratified according to gestational age groups mentioned

    immediately after delivery for study cases through study completion, an average of 1 year

Secondary Outcomes (3)

  • The incidence of miscarriage.

    immediately after occurrence of miscarriage through study completion, an average of 1 year

  • Incidence of cervico-vaginal infection

    once reported or confirmed during pregnancy through study completion, an average of 1 year

  • Incidences of bad Neonatal outcomes in both groups

    during early neonatal follow up through study completion, an average of 1 year

Study Arms (2)

Group A

EXPERIMENTAL

cervical cerclage between 14 and 20 weeks will be done by one of the three authors. McDonald cervical cerclage.

Procedure: Cervical cerclage

Group B

NO INTERVENTION

Routine antenatal care without cerclage

Interventions

Cervical cerclagePROCEDURE

McDonald cervical cerclage will be applied using Mersaline braided tape with double needle. Single stitch (4 bites) will be applied as close as possible to the level of internal os. The Knot will be put either anterior or posterior according to the surgeon desire.

Group A

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant ladies
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-50 years.
  • Dichorionic twins.
  • History of ≥1 preterm birth.
  • Transvaginal sonographic cervical length is ≥25 mm at 14-20 weeks gestational age.
  • Asymptomatic.

You may not qualify if:

  • Triplets and quadruplets.
  • Monochorionic twins.
  • Threatened/ inevitable miscarriage
  • Bulging membranes through the external os.
  • Extremes of age.
  • Major fetal anomalies.
  • Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis… etc.
  • Fetal demise.
  • Fetal reduction in the current pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Amro El Nemr

    Zagazig University

    PRINCIPAL INVESTIGATOR

  • Mohamed Lashin

    Zagazig University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hytham Atia

CONTACT

+966538308500hythamatia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 11, 2021

First Posted

April 19, 2022

Study Start

December 20, 2021

Primary Completion

September 28, 2023

Study Completion

October 15, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)