NCT03837288

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Preterm Labor
• Cervical Incompetence

Interventions

Type	Name	Description
PROCEDURE	Cerclage	Cervical cerclage under effect of spinal anaesthesia

Timeline

• Start date: 2019-04-22
• Primary completion: 2019-09-20
• Completion: 2019-10-22
• First posted: 2019-02-12
• Last updated: 2019-02-12

Locations

1 site across 1 country: Egypt