Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix

Aswan University Hospital

Status: Unknown

Conditions: Twin; Pregnancy, Affecting Fetus or Newborn

Treatments: Procedure: Cervical cerclage; Drug: vaginal progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT03781466

aswu/190/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Cervical cerclage

Active Comparator group

Description:

Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm

Treatment:

Procedure: Cervical cerclage

vaginal progesterone

Active Comparator group

Description:

Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks

Treatment:

Drug: vaginal progesterone

Cervical cerclage plus vaginal progesterone

Active Comparator group

Description:

Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks

Treatment:

Drug: vaginal progesterone

Procedure: Cervical cerclage