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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2019-10-22

Brief Summary

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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.

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Detailed Description

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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

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Preterm Labor Cervical Incompetence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vaginal progesterone only

continue on vaginal progesterone only

Group Type NO_INTERVENTION

No interventions assigned to this group

Cervical cerclage plus vaginal progesterone

cerclage with vaginal progesterone.

Group Type EXPERIMENTAL

Cerclage

Intervention Type PROCEDURE

Cervical cerclage under effect of spinal anaesthesia

Interventions

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Cerclage

Cervical cerclage under effect of spinal anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes