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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Manal Mohammed Fawzy, Ain Shams University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Preterm Labor Cervical Incompetence Procedure: Cerclage Not Applicable

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 :

  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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Vaginal progesterone only
continue on vaginal progesterone only
Experimental: Cervical cerclage plus vaginal progesterone
cerclage with vaginal progesterone.
Procedure: Cerclage
Cervical cerclage under effect of spinal anaesthesia




Primary Outcome Measures :
  1. Gestational age of delivery [ Time Frame: <37 weeks ]
    After 37 weeks of pregnancy


Secondary Outcome Measures :
  1. New born birth weight [ Time Frame: At time of birth ]
    less than 2 kg



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Singleton pregnant.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Manal Fawzy 01012659658 manoly18loly@gmail.com
Contact: Al Hassan Khedr 01006193797 Hasankhedr@gmail.com

Locations
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Egypt
AinshamsU Recruiting
Cairo, Egypt, +02
Contact: Manal Fawzy, Bachalori    01012659658    manoly18loly@gmail.com   
Contact: Al Hassan Khedr, MD    01006193797    hasankhedr@gmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Yasser Shahawy Ain Shams University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manal Mohammed Fawzy, Principle invistigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03837288    
Other Study ID Numbers: Trial
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manal Mohammed Fawzy, Ain Shams University:
preterm labor
cerclage
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Uterine Cervical Incompetence
Obstetric Labor Complications
Pregnancy Complications
Uterine Cervical Diseases
Uterine Diseases
Abortion, Habitual
Abortion, Spontaneous