Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cervical Pessary vs Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02470676
Recruitment Status : Not yet recruiting
First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:

The purpose of this randomized control trial is to determine whether cervical pessary plus vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic mid-pregnancy short cervix, in singleton and twin gestations.

All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24 completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in the clinical trial.

Women who meet eligible criteria will be invited to participate in the clinical trial.

Women will be randomly assigned into one of the following groups: group A (vaginal progesterone) or group B (vaginal progesterone + pessary).

Follow-up visits for ultrasound assessment of fetal growth and cervical length will be carried out every two weeks until 37 weeks of gestation.


Condition or disease Intervention/treatment Phase
Preterm Birth Short Cervix Device: Pessary Drug: Progesterone Phase 2 Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cervical Pessary vs. Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Progesterone
200 mg daily of vaginal progesterone suppositories (Utrogestan)
Drug: Progesterone
200 mg daily of vaginal progesterone suppositories (Utrogestan)

Experimental: Progesterone plus Experimental device
Experimental device + 200 mg daily progesterone vaginal suppositories (Utrogestan)
Device: Pessary
Two optional pessary sizes with the following dimensions: 65/17/35 or 70/17/35 and 200 mg daily progesterone vaginal suppositories (Utrogestan)




Primary Outcome Measures :
  1. preterm birth before 34 weeks of gestation rate in singleton pregnancies [ Time Frame: up to 20 weeks from recruitment ]
  2. preterm birth before 32 weeks of gestation rate in twin pregnancies [ Time Frame: up to 20 weeks from recruitment ]

Secondary Outcome Measures :
  1. Other preterm birth age before 34, 28 weeks in twin pregnancies [ Time Frame: up to 20 weeks from recruitment ]
  2. Neonatal/perinatal complications rate [ Time Frame: up to 20 weeks from recruitment ]
    Respiratory Distress Syndrome (RDS), necrotizing enterocolitis, intraventricular hemorrhage, proven neonatal sepsis, retinopathy of prematurity, bronchopulmonary dysplasia, periventricular leukomalacia, fetal death, neonatal death. Apgar score <7 at 5 minutes, birth weight <1500 g and <2500 g, use of mechanical ventilation, congenital anomaly.

  3. Maternal Adverse events [ Time Frame: up to 20 weeks from recruitment ]
    vaginal discharge, vaginal pruritus, discontinuation of treatment because of adverse events, threatened preterm labor.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed to be pregnant at up to 24+0 weeks of gestation, with a cervical length measurement of ≤25 mm with a singleton pregnancy, or ≤38 mm in twins pregnancy.
  • Does not meet with maternal/fetal/membrane/placental factors detailed in the exclusion criteria.
  • Willingness to comply with the protocol for the duration of the study.
  • Have signed an informed consent.

Exclusion Criteria:

  • Fetal factors: major fetal abnormalities, death of one or both of the fetuses, twins- twin-to-twin transfusion syndrome, and severe growth retardation.
  • Maternal factors: prophylactic cervical cerclage in situ, painful regular uterine contractions, active labor, active vaginal bleeding, maternal age under 18, uterine abnormalities (i.e. two cervices), and severe uterine prolapse.
  • Membranes and placental factors: placenta previa, ruptured membranes.

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): NCT02470676


Contacts
Layout table for location contacts
Contact: Asnat Walfisch, MD +972 50 4492200 asnatwalfisch@yahoo.com
Contact: Dvir Reder, MD +972 52 6131383 dvir.reder@gmail.com

Sponsors and Collaborators
Hillel Yaffe Medical Center

Layout table for additonal information
Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02470676     History of Changes
Other Study ID Numbers: 0096-14-HYMC
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs