NCT02673359

Brief Summary

The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.

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
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

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

February 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

7.8 years

First QC Date

February 1, 2016

Last Update Submit

April 6, 2023

Conditions

Premature Labour

Keywords

Preterm laborShort cervixProgesteroneCervical cerclage

Outcome Measures

Primary Outcomes (1)

  • Preterm labor before 35 weeks

    Up to 35 weeks gestational age

Secondary Outcomes (4)

  • Delivery before 37 weeks

    Up to 37 weeks gestational age

  • Low birth weight (LBW)

    At birth

  • Neonatal respiratory distress syndrome (RDS)

    At birth

  • Early neonatal death (END)

    One month after birth

Study Arms (2)

Progesterone group

ACTIVE COMPARATOR

Vaginal progesterone suppositories will be given

Drug: Progesterone

Cerclage group

ACTIVE COMPARATOR

Cervical cerclage will be performed.

Procedure: Cervical cerclage

Interventions

ProgesteroneDRUG

Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day

Also known as: Cyclogest, Prontogest
Progesterone group
Cervical cerclagePROCEDURE

Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)

Also known as: Cervical stitch
Cerclage group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with singleton pregnancy.
  • History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
  • Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.

You may not qualify if:

  • Age \< 20 or \> 35 years.
  • Congenital uterine malformation.
  • Multifetal pregnancy.
  • Known major fetal structural or chromosomal abnormality.
  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Presence of contraindication to cervical cerclage.
  • Medical conditions complicating pregnancy.
  • Vaginal bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

Private practice settings

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

Obstetrics and Gynecology Department in Port Said University

Port Said, Egypt

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

ProgesteroneCerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid HormonesObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Waleed El-refaie, Dr

    Port Said University

    PRINCIPAL INVESTIGATOR

  • Mohamed S Abdelhafez, Dr

    Mansoura University

    STUDY DIRECTOR

  • Ahmed M Badawy, Prof

    Mansoura University

    STUDY CHAIR

Central Study Contacts

Waleed El-refaie, Dr

CONTACT

wrefaie@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

April 10, 2023

Record last verified: 2023-04

Locations

EG(3)