Clinical trial NCT02673359: Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM
Official title: Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Premature Labour
Keywords: Preterm labor
Short cervix
Progesterone
Cervical cerclage
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Preterm labor before 35 weeks
timeFrame: Up to 35 weeks gestational age
Secondary outcomes:
measure: Delivery before 37 weeks
timeFrame: Up to 37 weeks gestational age
measure: Low birth weight (LBW)
timeFrame: At birth
measure: Neonatal respiratory distress syndrome (RDS)
timeFrame: At birth
measure: Early neonatal death (END)
timeFrame: One month after birth
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
city: Mansourah
country: Egypt
facility: Private practice settings
state: Dakahlia
city: Port Said
country: Egypt
facility: Obstetrics and Gynecology Department in Port Said University
Study officials:
affiliation: Port Said University
name: Waleed El-refaie, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Ahmed M Badawy, Prof
role: STUDY_CHAIR
References: