Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone

Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01317225

Enrollment

Registered

2011-03-17

Start date

2011-06-30

Completion date

2015-08-31

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labor, Premature, Preterm Birth

Keywords

Progesterone, Obstetric labor, premature, Short cervix

Brief summary

The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.

Detailed description

Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.

Interventions

DRUG17 α hydroxyprogesterone caproate

250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.

DRUGPlacebo

250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Pregnant women between 26 and 34 weeks of gestation. * Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.

Exclusion criteria

* Multiple gestations. * Maternal pathologies in which preterm termination of pregnancy is required.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of preterm birth (before 37 weeks of gestation)	18 months	Number of patients that delivered before 37 weeks of pregnancy

Secondary

Measure	Time frame	Description
Incidence of preterm birth before 35 weeks of pregnancy	18 months	To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 35 weeks of gestation in patients with a previous episode of threatened preterm labor.
Incidence of preterm birth before 32 weeks of pregnancy	18 months	To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 32 weeks of gestation in patients with a previous episode of threatened preterm labor.

Countries

Panama

Contacts

Primary ContactOsvaldo A Reyes, MD (Gyn/Ob)

oreyesmaternidad@gmail.com011(507)65655041

Backup ContactRodrigo Velarde, MD (Gyn/Ob)

revelarde_14@yahoo.es011(507)66159954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026