Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening

February 9, 2019 updated by: Manal Mohammed Fawzy, Ain Shams University

The aim of this study is to

Determine whether cerclage with vaginal progesterone will:

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

Research question:

Does cervical cerclage reduce the overall spontaneous preterm births in patients with progressive cervical shortening.

Research Hypothesis In this current study, the investigators hypothesize that cervical cerclage reduces spontaneous preterm births in patients with progressive cervical shortening on vaginal progesterone only.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial The study will be done in Ain Shams University Hospital including women attending antenatal care clinic in Ain Shams University Hospital.

All patients entering the trial will be counselled and will sign a written consent explaining the details of the trial. All the patients included in this study will undergo routine Fetal anomaly scan at 18-24 weeks.Patients with cervical length < 20 mm in routine anomaly scan will :

  1. Receive vaginal progesterone suppositories 200 mg daily.. (All patients will be continued with vaginal progesterone until 37 completed weeks or until they develop preterm rupture of membrane or preterm delivery).
  2. Undergo routine follow up of cervical length every 1 to 2 weeks. Patients with progressive shortening of cervical length less than 10 mm during routine follow up, will have the option of continuing vaginal progesterone daily (Progesterone 200 mg vaginal suppositories) alone, or having cervical cerclage placed in addition to daily vaginal progesterone.

In cerclage group: all patients will sign a written consent for approval of cervical cerclage.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Vaginal progesterone only
continue on vaginal progesterone only
Experimental: Cervical cerclage plus vaginal progesterone
cerclage with vaginal progesterone.
Procedure: Cerclage
Cervical cerclage under effect of spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age of delivery
Time Frame: <37 weeks
After 37 weeks of pregnancy
<37 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New born birth weight
Time Frame: At time of birth
less than 2 kg
At time of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Yasser Shahawy, Ain shams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 22, 2019

Primary Completion (Anticipated)

September 20, 2019

Study Completion (Anticipated)

October 22, 2019

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

February 9, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 9, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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