Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
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|ClinicalTrials.gov Identifier: NCT03837288|
Recruitment Status : Unknown
Verified February 2019 by Manal Mohammed Fawzy, Ain Shams University.
Recruitment status was: Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
The aim of this study is to
Determine whether cerclage with vaginal progesterone will:
- Reduce the overall spontaneous preterm birth rate.
- Prolong pregnancy latency.
- Improve neonatal outcome. Compared to vaginal progesterone only, in patients with progressive cervical shortening.
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||Not Applicable|
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 :
- 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).
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening|
|Estimated Study Start Date :||April 22, 2019|
|Estimated Primary Completion Date :||September 20, 2019|
|Estimated Study Completion Date :||October 22, 2019|
No Intervention: Vaginal progesterone only
continue on vaginal progesterone only
Experimental: Cervical cerclage plus vaginal progesterone
cerclage with vaginal progesterone.
Cervical cerclage under effect of spinal anaesthesia
- Gestational age of delivery [ Time Frame: <37 weeks ]After 37 weeks of pregnancy
- New born birth weight [ Time Frame: At time of birth ]less than 2 kg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837288
|Contact: Manal Fawzyemail@example.com|
|Contact: Al Hassan Khedr||01006193797||Hasankhedr@gmail.com|
|Study Director:||Yasser Shahawy||Ain Shams University|