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

• Sponsor: Ain Shams University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03837288
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Labor; Cervical Incompetence	Procedure: Cerclage	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
• Anticipated Study Start Date: Apr 22, 2019
• Anticipated Primary Completion Date: Sep 20, 2019
• Anticipated Study Completion Date: Oct 22, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Gestational age of delivery [<37 weeks]

   After 37 weeks of pregnancy

Secondary Outcome Measures

1. New born birth weight [At time of birth]

   less than 2 kg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AinshamsU	Cairo		Egypt	+02

Sponsors and Collaborators

• Ain Shams University

Investigators

• Study Director: Yasser Shahawy, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manal Mohammed Fawzy, Principle invistigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03837288
• Other Study ID Numbers: Trial
• First Posted: Feb 12, 2019
• Last Update Posted: Feb 12, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Manal Mohammed Fawzy, Principle invistigator, Ain Shams University: preterm labor; cerclage
• Additional relevant MeSH terms: Obstetric Labor, Premature; Uterine Cervical Incompetence

Study Results

No Results Posted as of Feb 12, 2019