Prevention of Preterm Birth With a Pessary in Singleton Gestations

NCT02056652 | Completed Results DMC

• 1 other identifier: 817797
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 4

Brief Summary

Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. 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

Preterm Birth; Short Cervix

Keywords

Preterm birth; Preterm delivery; short cervix; pessary

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Experiencing Preterm Birth

  Birth before 37 weeks gestation was captured.

  Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)

Secondary Outcomes (5)

• Average Birth Weight of Babies Born on Trial

  Time of delivery

• Number of Participants That Experienced Spontaneous Preterm Births on Trial

  Before 37 weeks gestation

• Number of Participants Experiencing Spontaneous Rupture of Membranes

  Less than 34 weeks gestation

• Number of Subjects Experiencing 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 23 6/7 weeks gestation, and will be removed during the 37th 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
• Singleton pregnancy (limits the participants to female gender)
• Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation

You may not qualify if:

• Multiple gestation
• Prior spontaneous preterm birth 16-36 6/7 weeks
• 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 or CL = 0 mm on transvaginal ultrasound
• Painful regular uterine contractions
• Placenta previa

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (4)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

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

Related Publications (1)

• Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508.

  PMID: 36453699 DERIVED

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

Our main limitation was the small sample size due to the fact that the study was stopped before planned enrollment was completed. In order to reach significance, we would need for the next 60 subjects randomized to the pessary group.

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, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Jack Ludmir, MD

  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: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 29, 2018
• Results First Posted: May 29, 2018

Record last verified: 2018-04

Locations

US (4)