Cerclage for Twins With Short Cervix

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03077633
• Other study ID #: OBX0038
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: March 3, 2017
• Last updated: March 20, 2018
• Start date: October 1, 2017
• Est. completion date: January 17, 2018

Study information

• Verified date: March 2018
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 17, 2018
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Incompetence
• Cervical Shortening
• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth
• Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2
• Uterine Cervical Incompetence

Intervention

Procedure:
• Cervical Cerclage placement
Cervical Cerclage placement

Drug:
• Vaginal Progesterone
200mg tab of vaginal progesterone administered daily from time of randomization until delivery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of very preterm birth (PTB)	Rate of very PTB (PTB less than 32 weeks)	Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.
Primary	Rate of adverse perinatal outcome	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.	Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.