Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
Primary Purpose
Preterm Labor, Cervical Incompetence
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cerclage
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Labor focused on measuring preterm labor, cerclage
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.
Sites / Locations
- AinshamsURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Vaginal progesterone only
Cervical cerclage plus vaginal progesterone
Arm Description
continue on vaginal progesterone only
cerclage with vaginal progesterone.
Outcomes
Primary Outcome Measures
Gestational age of delivery
After 37 weeks of pregnancy
Secondary Outcome Measures
New born birth weight
less than 2 kg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03837288
Brief Title
Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
Official Title
Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 22, 2019 (Anticipated)
Primary Completion Date
September 20, 2019 (Anticipated)
Study Completion Date
October 22, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor, Cervical Incompetence
Keywords
preterm labor, cerclage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal progesterone only
Arm Type
No Intervention
Arm Description
continue on vaginal progesterone only
Arm Title
Cervical cerclage plus vaginal progesterone
Arm Type
Experimental
Arm Description
cerclage with vaginal progesterone.
Intervention Type
Procedure
Intervention Name(s)
Cerclage
Intervention Description
Cervical cerclage under effect of spinal anaesthesia
Primary Outcome Measure Information:
Title
Gestational age of delivery
Description
After 37 weeks of pregnancy
Time Frame
<37 weeks
Secondary Outcome Measure Information:
Title
New born birth weight
Description
less than 2 kg
Time Frame
At time of birth
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Singleton pregnant.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Fawzy
Phone
01012659658
Email
manoly18loly@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Al Hassan Khedr
Phone
01006193797
Email
Hasankhedr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Shahawy
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
AinshamsU
City
Cairo
ZIP/Postal Code
+02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal Fawzy, Bachalori
Phone
01012659658
Email
manoly18loly@gmail.com
First Name & Middle Initial & Last Name & Degree
Al Hassan Khedr, MD
Phone
01006193797
Email
hasankhedr@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32970845
Citation
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.
Results Reference
derived
Learn more about this trial
Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
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