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

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837288
• Other study ID #: Trial
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: October 22, 2019

Study information

• Verified date: February 2019
• Source: Ain Shams University
• Contact: Manal Fawzy
• Phone: 01012659658
• Email: manoly18loly[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 22, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Incompetence
• Obstetric Labor, Premature
• Preterm Labor
• Uterine Cervical Incompetence

Intervention

Procedure:
• Cerclage
Cervical cerclage under effect of spinal anaesthesia

Locations

Country	Name	City	State
Egypt	AinshamsU	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age of delivery	After 37 weeks of pregnancy	<37 weeks
Secondary	New born birth weight	less than 2 kg	At time of birth