Cerclage for Twins With Short Cervix

Phase 2

Withdrawn

• Conditions: Preterm Birth; Cervical Incompetence; Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2; Cervical Shortening
• Interventions: Procedure: Cervical Cerclage placement; Drug: Vaginal Progesterone

• Registration Number: NCT03077633
• Lead Sponsor: Pediatrix

Brief Summary

A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (\</= 15.0mm) between 16w0d to 25w6d.

Detailed Description

A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB\<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.

Study Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-13
• Study Start: 2017-10-01
• Primary Completion: 2018-01-17
• Study Completion: 2018-01-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Twin pregnancy (see Exclusion Criterion (a) below re: monochorionic twins)
• Gestational age 16 0/7 to 25 6/7 weeks at time of enrollment by best-estimated age.
• Cervical length 0.1 to 15.0 mm on transvaginal ultrasound examination. (Cervical length is taken to mean the length of the closed portion of the cervical canal.

Exclusion Criteria

• Maternal age less than 18 years
• Monochorionic twins (such as monochorionic-diamniotic, monochorionic-monoamniotic, or conjoined twins)
• Rupture of membranes, either twin
• One or both twins has no cardiac activity
• One or both twins has known or suspected major malformation, aneuploidy, or polyhydramnios
• Maternal congenital uterine anomaly (such as bicornuate uterus, unicornuate uterus)
• Pregnancy started as triplets or higher-order multifetal gestation and then reduced to twins, either spontaneously or via procedure
• Symptomatic uterine contractions, 6 or more per hour
• Ongoing bleeding from uterus
• Patient declines to consider cerclage
• Patient declines treatment with vaginal progesterone
• Allergy to progesterone or peanuts (because the vaginal progesterone formulation used will be a capsule of micronized progesterone in peanut oil.)
• Cerclage is already in place
• Cerclage placement is judged to be technically impossible
• Patient has a history of poor follow-up or poor adherence to physician recommendations
• Patient is planning to relocate outside the local area before the end of pregnancy such that delivery records will be unavailable
• Patient does not give consent to participate in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical Cerclage + Progesterone	Vaginal Progesterone	Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)
Progesterone	Vaginal Progesterone	Daily administration of vaginal progesterone (200mg tab)
Cervical Cerclage + Progesterone	Cervical Cerclage placement	Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)

Primary Outcome Measures

Name	Time	Method
Rate of very preterm birth (PTB)	Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.	Rate of very PTB (PTB less than 32 weeks)
Rate of adverse perinatal outcome	Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.	The rate of adverse perinatal outcome defined as any one or more of the following: Miscarriage, stillbirth, neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (grade III or IV), necrotizing enterocolitis, culture proven sepsis.