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Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor

NCT01523483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-04-22

No results posted yet for this study

Summary

The investigators study objective is to investigate the effectiveness of vaginal micronized progesterone in prolonging pregnancy after an episode of preterm labor which responded to tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of actions of progesterone supplementation by examining its effect on the two components of parturition: cervical ripening and myometrial contractility. The investigators will utilize transvaginal ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal uterine EMG to assess the uterine muscle activity. The investigators will also look at the effect of progesterone on contraction frequency by tocodynamometer (TOCO), though EMG is expected to provide much more information.

Conditions

Interventions

DRUG

Progesterone

Two micronized progesterone capsules (Utrogestan® 200 mg, i.e. 400 mg of micronized progesterone in sunflower oil) placed into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.

DRUG

placebo vaginal capsules

Two placebo capsules placed (soy lecithin and sunflower oil) into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.

Sponsors & Collaborators

  • Slovenian Research Agency

    collaborator OTHER

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Ziva Novak Antolic, PhD, MD · University Medical Centre Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01523483 on ClinicalTrials.gov