- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03077633
Cerclage for Twins With Short Cervix
March 20, 2018 updated by: Pediatrix
Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Cervical Cerclage + Progesterone
Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)
|
Cervical Cerclage placement
200mg tab of vaginal progesterone administered daily from time of randomization until delivery.
Other Names:
|
PLACEBO_COMPARATOR: Progesterone
Daily administration of vaginal progesterone (200mg tab)
|
200mg tab of vaginal progesterone administered daily from time of randomization until delivery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of very preterm birth (PTB)
Time Frame: 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)
|
Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.
|
Rate of adverse perinatal outcome
Time Frame: 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.
|
Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Combs, MD, Pediatrix
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2017
Primary Completion (ACTUAL)
January 17, 2018
Study Completion (ACTUAL)
January 17, 2018
Study Registration Dates
First Submitted
March 3, 2017
First Submitted That Met QC Criteria
March 10, 2017
First Posted (ACTUAL)
March 13, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 21, 2018
Last Update Submitted That Met QC Criteria
March 20, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Uterine Cervical Diseases
- Uterine Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Abortion, Habitual
- Abortion, Spontaneous
- Premature Birth
- Obstetric Labor, Premature
- Uterine Cervical Incompetence
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Progestins
- Progesterone
Other Study ID Numbers
- OBX0038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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