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
Verified date | March 2018 |
Source | Mednax Center for Research, Education, Quality and Safety |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Mednax Center for Research, Education, Quality and Safety |
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. |
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