Cervical Cerclage for Singleton Pregnant on Vaginal Proge... | NCT03837288

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

NCT03837288

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Feb 12, 2019Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Preterm Labor
Cervical Incompetence

Interventions

Cerclage

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2019Estimated

Primary Completion Date

Sep 20, 2019Estimated

Completion Date

Oct 22, 2019Estimated

First Submitted Date

Jan 8, 2019

First Submission Date that Met QC Criteria

Feb 9, 2019

First Posted Date

Feb 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2019

Last Update Posted Date

Feb 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Manal Mohammed Fawzy, Principle invistigator, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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 :

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal progesterone only	No Intervention	continue on vaginal progesterone only
Cervical cerclage plus vaginal progesterone	Experimental	cerclage with vaginal progesterone.	Procedure: Cerclage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cerclage	Procedure	Cervical cerclage under effect of spinal anaesthesia	Cervical cerclage plus vaginal progesterone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gestational age of delivery	After 37 weeks of pregnancy	<37 weeks

Secondary Outcomes

Measure	Description	Time Frame
New born birth weight	less than 2 kg	At time of birth

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged: 20-38 years old.
Single living fetus.
The patient does not have history of preterm labor (before 37 weeks of gestation)
No history of cervical or uterine anomalies.

Exclusion Criteria:

Congenital anomalies in the fetus discovered during the follow up.
History of spontaneous preterm births.
Evidence of imminent delivery, or uterine contractions.
Evidence of rupture of membranes, or intra amniotic infection.
Intra uterine fetal death.
Uterine or cervical anomalies.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Singleton pregnant.

Minimum Age

20 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manal Fawzy	Contact	01012659658		manoly18loly@gmail.com
Al Hassan Khedr	Contact	01006193797		Hasankhedr@gmail.com

Overall Officials

Name	Affiliation	Role
Yasser Shahawy	Ain Shams University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AinshamsU	Recruiting	Cairo		+02	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32970845	Derived	Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.

ID	Term
D007752	Obstetric Labor, Premature
D002581	Uterine Cervical Incompetence

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative