Prevention of Preterm Birth With a Pessary in Twin Gestations

NCT02056639 | Completed Results DMC

• 1 other identifier: 819122
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births has risen substantially due to the increased use of assisted reproductive technology. The rate of twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and 2004. The increased rate of PTB in twins is associated with increased morbidity and mortality rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United States are twins, as are one in six infants who die in the first month of life. Cervical shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. There is currently no effective treatment to decrease the incidence of PTB in women with twin gestations, but there is some evidence that the use of a cervical pessary in women with a short cervix has promise. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.

Conditions

Premature Birth; Short Cervix

Keywords

Premature birth; Premature delivery; Short cervix; Pessary

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Preterm Delivery

  Less than 34 weeks gestation

Secondary Outcomes (4)

• Average Birth Weight of Babies in Each Group

  Time of delivery

• Spontaneous Preterm Birth Rates

  Less than 37 weeks gestation

• Number of Participants That Experienced Neonatal Death

  Between birth and 28 days of age

• Number of Subjects Experiencing Chorioamnionitis

  Time of delivery

Study Arms (2)

Pessary

EXPERIMENTAL

Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)

Device: Bioteque cup pessary

No pessary

NO INTERVENTION

No pessary will be used. Subjects will receive standard obstetrical management

Interventions

Bioteque cup pessary DEVICE

Pessary

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Twin pregnancy (limits the participants to female gender)
• Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-27 6/7 weeks gestation

You may not qualify if:

• Singleton or higher order than twins multiple gestation
• Monoamniotic twins
• Twin twin transfusion syndrome
• Ruptured membranes
• Lethal fetal structural anomaly
• Fetal chromosomal abnormality
• Cerclage in place (or planned placement)
• Vaginal bleeding
• Suspicion of chorioamnionitis
• Ballooning of membranes outside the cervix into the vagina
• Painful regular uterine contractions
• Labor
• Placenta previa

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (3)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

The main limitation of our study was the fact that it was stopped before planned enrollment was complete, which resulted in a small sample size.

Results Point of Contact

• Title: Bridget Nolan
• Organization: University of Pennsylvania

bridget.nolan@uphs.upenn.edu

2156623324

Study Officials

• Lorraine Dugoff, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Vincenzo Berghella

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Jack Ludmir

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 6, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 29, 2018
• Results First Posted: May 29, 2018

Record last verified: 2018-04

Locations

US (3)