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Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM

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ClinicalTrials.gov Identifier: NCT02673359
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

Brief Summary:
The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.

Condition or disease Intervention/treatment Phase
Premature Labour Drug: Progesterone Procedure: Cervical cerclage Phase 4

Detailed Description:
Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage
Study Start Date : February 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Progesterone group
Vaginal progesterone suppositories will be given
Drug: Progesterone
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
Other Names:
  • Cyclogest
  • Prontogest

Active Comparator: Cerclage group
Cervical cerclage will be performed.
Procedure: Cervical cerclage
Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)
Other Name: Cervical stitch




Primary Outcome Measures :
  1. Preterm labor before 35 weeks [ Time Frame: Up to 35 weeks gestational age ]

Secondary Outcome Measures :
  1. Delivery before 37 weeks [ Time Frame: Up to 37 weeks gestational age ]
  2. Low birth weight (LBW) [ Time Frame: At birth ]
    Birth weight of a living neonate of < 2500 gm regardless of gestational age

  3. Neonatal respiratory distress syndrome (RDS) [ Time Frame: At birth ]
  4. Early neonatal death (END) [ Time Frame: One month after birth ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with singleton pregnancy.
  • History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
  • Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.

Exclusion Criteria:

  • Age < 20 or > 35 years.
  • Congenital uterine malformation.
  • Multifetal pregnancy.
  • Known major fetal structural or chromosomal abnormality.
  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Presence of contraindication to cervical cerclage.
  • Medical conditions complicating pregnancy.
  • Vaginal bleeding.

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): NCT02673359


Contacts
Contact: Waleed El-refaie, Dr wrefaie@yahoo.com

Locations
Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital Recruiting
Mansourah, Dakahlia, Egypt, 35111
Private practice settings Recruiting
Mansourah, Dakahlia, Egypt
Obstetrics and Gynecology Department in Port Said University Recruiting
Port Said, Egypt
Sponsors and Collaborators
Mohamed Sayed Abdelhafez
Investigators
Principal Investigator: Waleed El-refaie, Dr Mansoura University
Study Director: Mohamed S Abdelhafez, Dr Mansoura University
Study Chair: Ahmed M Badawy, Prof Mansoura University

Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02673359     History of Changes
Other Study ID Numbers: WR2
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
Preterm labor
Short cervix
Progesterone
Cervical cerclage

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs