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Completed

NCT Number: NCT02056639

Prevention of Preterm Birth With a Pessary in Twin Gestations

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-50 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

Exclusion criteria

  • 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

Treatment and study plan

Bioteque cup pessary

Device

Primary outcomes

  1. Number of Participants With Preterm Delivery

    Time frame: Less than 34 weeks gestation

Secondary outcomes

  1. Average Birth Weight of Babies in Each Group

    Time frame: Time of delivery

    The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.

  2. Spontaneous Preterm Birth Rates

    Time frame: Less than 37 weeks gestation

  3. Number of Participants That Experienced Neonatal Death

    Time frame: Between birth and 28 days of age

    Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.

  4. Number of Subjects Experiencing Chorioamnionitis

    Time frame: Time of delivery

    Chorioamnionitis was recorded and analyzed for participants in each group.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: PoPPT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2014
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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