Cerclage for Twins With Short Cervix

Sponsor

Mednax Center for Research, Education, Quality and Safety (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03077633

Collaborator

(none)

Enrollment

Arms

3.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2 Cervical Incompetence Cervical Shortening	Procedure: Cervical Cerclage placement Drug: Vaginal Progesterone	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups: Cerclage + Progesterone vs. Progesterone aloneTwo groups: Cerclage + Progesterone vs. Progesterone alone

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial

Anticipated Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Jan 17, 2018

Actual Study Completion Date :

Jan 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cervical Cerclage + Progesterone Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)	Procedure: Cervical Cerclage placement Cervical Cerclage placement Drug: Vaginal Progesterone 200mg tab of vaginal progesterone administered daily from time of randomization until delivery. Other Names: Prometrium
Placebo Comparator: Progesterone Daily administration of vaginal progesterone (200mg tab)	Drug: Vaginal Progesterone 200mg tab of vaginal progesterone administered daily from time of randomization until delivery. Other Names: Prometrium

Arm

Intervention/Treatment

Active Comparator: Cervical Cerclage + Progesterone

Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)

Procedure: Cervical Cerclage placement

Cervical Cerclage placement

Drug: Vaginal Progesterone

200mg tab of vaginal progesterone administered daily from time of randomization until delivery.

Other Names:

Prometrium

Placebo Comparator: Progesterone

Daily administration of vaginal progesterone (200mg tab)

Drug: Vaginal Progesterone

200mg tab of vaginal progesterone administered daily from time of randomization until delivery.

Other Names:

Prometrium

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.