Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth

NCT02511574 | Completed Phase 4

• 1 other identifier: 470.095
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effectiveness between the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervical length of 25 mm or less evaluated by transvaginal ultrasonography.

Conditions

Preterm Labor; Premature Birth

Keywords

progesterone; uterine cervix; cervical pessary

Outcome Measures

Primary Outcomes (1)

• Spontaneous preterm birth before 34 weeks of gestational age

  All births that occurred before 34 weeks of gestation were included, excluding iatrogenic births (medically indicated).

  before 34 weeks of gestation

Secondary Outcomes (4)

• Overall preterm birth before 37, 34, 32 and 30 weeks of gestational age

  before 37, 34, 32 and 30 weeks of gestation

• Spontaneous preterm birth before 37, 32 and 30 weeks of gestational age

  before 37, 32 and 30 weeks of gestation

• Adverse neonatal events

  Neonatal period (up to 27 days after birth)

• The need of neonatal special care

  Neonatal period (up to 27 days after birth)

Study Arms (2)

cervical pessary

EXPERIMENTAL

Patients with uterine cervical length ≤ 25 mm are randomized to use the cervical pessary or natural progesterone to compare their effectiveness in the reduction of preterm birth rates.

Device: cervical pessary

natural progesterone

ACTIVE COMPARATOR

Patients with uterine cervical length ≤ 25 mm are randomized to use the cervical pessary or natural progesterone to compare their effectiveness in the reduction of preterm birth rates.

Drug: natural progesterone

Interventions

natural progesterone DRUG

natural progesterone

cervical pessary DEVICE

cervical pessary

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• gestational age between 20 weeks and 23 weeks and 6 days
• singleton pregnancies

You may not qualify if:

• fetal death at randomization
• major structural or chromosomal abnormality
• cervical cerclage in the current pregnancy
• preterm rupture of membranes diagnosed before randomization

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doutor

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 30, 2015
• Study Start: August 3, 2015
• Primary Completion: December 10, 2022
• Study Completion: August 30, 2023
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

BR (1)