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Cerclage for Twins With Short Cervix

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ClinicalTrials.gov Identifier: NCT03077633
Recruitment Status : Withdrawn (Financial/business decision by Sponsor to not proceed with this study)
First Posted : March 13, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two 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
Estimated Study Start Date : October 1, 2017
Actual Primary Completion Date : January 17, 2018
Actual Study Completion Date : January 17, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Prometrium




Primary Outcome Measures :
  1. 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)

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077633


Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Investigators
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Principal Investigator: Andrew Combs, MD Mednax Center for Research, Education, Quality and Safety

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Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT03077633     History of Changes
Other Study ID Numbers: OBX0038
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mednax Center for Research, Education, Quality and Safety:
Cerclage
Cervical shortening
Twins
Progesterone

Additional relevant MeSH terms:
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Progesterone
Premature Birth
Obstetric Labor, Premature
Uterine Cervical Incompetence
Obstetric Labor Complications
Pregnancy Complications
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Abortion, Habitual
Abortion, Spontaneous
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs