Preterm Labor Clinical Trial
Official title:
Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
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.
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.
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