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NCT Number: NCT02484820

Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor

In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases.

After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%.

A pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies.

The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective.

To evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Minimal age of 18 years
  • Informed consent
  • Confirmation of dating of pregnancy by first trimester echography.
  • Episode of threatened preterm labour
  • Singleton between 24 and 34 weeks of gestation
  • Cervical length ≤20mm in cervimetry
  • Pulmonary maturation completed
  • ≤6 contractions by hour after 24 hours of tocolysis.

Exclusion criteria

  • Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
  • Spontaneous rupture of membranes at the time of randomization
  • Cervical cerclage in situ
  • Uterus malformations
  • Antecedent of conisation
  • Active vaginal bleeding, placenta previa
  • Intra-amniotic infection
  • Hydramnios
  • Maternal chronic pathology (hypertension, diabetes)
  • Anomaly of breathing foetal rate

Treatment and study plan

Silicone pessary

Device

Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months)

Primary outcomes

  1. Number of spontaneous delivery

    Time frame: 37 weeks of gestation

    Comparison of the number of spontaneous delivery before 37 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.

Secondary outcomes

  1. Number of spontaneous delivery

    Time frame: 34 weeks of gestation

    Comparison of the number of spontaneous delivery before 34 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.

  2. Number of spontaneous delivery

    Time frame: 28 weeks of gestation

    Comparison of the number of spontaneous delivery before 28 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.

  3. Number of admission for preterm labor

    Time frame: from date of randomization until the date of the delivery

    Comparison of the number of admission for preterm labor from date of randomization until the date of the delivery between the 2 groups.

  4. Number of fetal-neonatal death

    Time frame: at delivery

    Number of fetal-neonatal death at delivery

  5. Number of birth death

    Time frame: From date of delivery until 6 weeks after the date of term

    Number of birth death at delivery until 6 weeks after the date of term

  6. Number of patients with neonatal morbidity

    Time frame: From date of delivery until 6 weeks after the date of term

    Number of patient with neonatal morbidity at delivery until 6 weeks after the date of term

  7. Number of patients with increase of vaginal discharge

    Time frame: from date of randomization until the date of the delivery

    Comparison of the number of patients with increase of vaginal discharge from date of randomization until the date of the delivery between the 2 groups of the study.

  8. Number of patients with spontaneous pessary ejection

    Time frame: from date of randomization until the date of the delivery

    Comparison of the number of patients with pessary ejection from date of randomization until the date of the delivery between the 2 groups of the study.

  9. Number of patients with discomfort

    Time frame: from date of randomization until the date of the delivery

    Comparison of the number of patients with discomfort from date of randomization until the date of the delivery between the 2 groups of the study. The discomfort is measure by a standardized questionnaire.

  10. number of day between resolutive threatened preterm labor and delivery

    Time frame: At delivery

    Comparison of number of day between the two groups of the study

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial

Acronym: PREMAPESSAIRE

Important dates

Study start
2015
Primary completion
2022
Study completion
2023
First posted
Jun 30, 2015
Registry last updated
May 24, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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