Clinical trial NCT03781466: Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix
Official title: Effect of Cervical Cerclage With or Without Vaginal Progesterone Versus Vaginal Progesterone Alone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Twin; Pregnancy, Affecting Fetus or Newborn
Keywords: Preterm birth
Twin gestation
Vaginal progesterone
cervical cerclage
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial
Primary purpose: PREVENTION

Brief summary: The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Detailed description: There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Eligibility criteria: Inclusion Criteria:

* Women pregnant in dichorionic twins.
* Transvaginal sonographic cervical length is \<25 mm at 16-20 weeks gestational age.
* No symptoms, signs or other risk factors for preterm labor

Exclusion Criteria:

* Age \< 18 years or \> 45 years.
* Known allergy or contraindication (relative or absolute) to progesterone therapy.
* Monochorionic twins.
* Known major fetal structural or chromosomal abnormality.
* Intrauterine death of one fetus or death of both fetuses.
* Fetal reduction in the current pregnancy.
* Medical conditions that may lead to preterm delivery.
* Rupture of membranes.
* Vaginal bleeding

Primary outcomes:
measure: Preterm labor before 34 weeks
timeFrame: Up to 34 weeks gestational age
Secondary outcomes:
measure: Neonatal respiratory distress syndrome
timeFrame: At birth
measure: Early neonatal death
timeFrame: within one month postpartum
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: