NCT03837288

Brief Summary

The aim of this study is to Determine whether cerclage with vaginal progesterone will:

  1. 1.Reduce the overall spontaneous preterm birth rate.
  2. 2.Prolong pregnancy latency.
  3. 3.Improve neonatal outcome. Compared to vaginal progesterone only, in patients with progressive cervical shortening.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

January 8, 2019

Last Update Submit

February 9, 2019

Conditions

Preterm LaborCervical Incompetence

Keywords

preterm laborcerclage

Outcome Measures

Primary Outcomes (1)

  • Gestational age of delivery

    After 37 weeks of pregnancy

    <37 weeks

Secondary Outcomes (1)

  • New born birth weight

    At time of birth

Study Arms (2)

Vaginal progesterone only

NO INTERVENTION

continue on vaginal progesterone only

Cervical cerclage plus vaginal progesterone

EXPERIMENTAL

cerclage with vaginal progesterone.

Procedure: Cerclage

Interventions

CerclagePROCEDURE

Cervical cerclage under effect of spinal anaesthesia

Cervical cerclage plus vaginal progesterone

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSingleton pregnant.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged: 20-38 years old.
  • Single living fetus.
  • The patient does not have history of preterm labor (before 37 weeks of gestation)
  • No history of cervical or uterine anomalies.

You may not qualify if:

  • Congenital anomalies in the fetus discovered during the follow up.
  • History of spontaneous preterm births.
  • Evidence of imminent delivery, or uterine contractions.
  • Evidence of rupture of membranes, or intra amniotic infection.
  • Intra uterine fetal death.
  • Uterine or cervical anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinshamsU

Cairo, +02, Egypt

RECRUITING

Related Publications (1)

  • Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.

    PMID: 32970845DERIVED

MeSH Terms

Conditions

Obstetric Labor, PrematureUterine Cervical Incompetence

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesAbortion, HabitualAbortion, SpontaneousGenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yasser Shahawy

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Manal Fawzy

CONTACT

01012659658manoly18loly@gmail.com

Al Hassan Khedr

CONTACT

01006193797Hasankhedr@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 8, 2019

First Posted

February 12, 2019

Study Start

April 22, 2019

Primary Completion

September 20, 2019

Study Completion

October 22, 2019

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

EG(1)