Skip to main content
OpenTrials
Completed

NCT Number: NCT01523483

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

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.

Completed

Looking for future studies?

Notify Me

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–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Univerity Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with singleton pregnancies at gestational ages 25+0 to 33+6 weeks after an episode of preterm labor, with cervical length ≤25mm:
  • Patients presenting with signs and symptoms of preterm labor will be admitted and given the standard treatment for preterm labor, i.e. tocolysis for 48 hours, and antenatal steroids.
  • Those who will remain undelivered for 48 hours and will be found to have a cervical length of 25mm or less will be offered entrance into the study.
  • Preterm labor will be defined as at least 4 contractions in 30 minutes with cervical change assessed by digital cervical examination.

Exclusion criteria

  • Patients with preterm premature rupture of membranes (PPROM) will be excluded from the study, due to the possibility of ascending infection, as will those with suspected chorioamnionitis.
  • We will not include multiple pregnancies.
  • Patients with medical conditions that contraindicate tocolysis, such as non-reassuring fetal heart tracings, will also be excluded.

Treatment and study plan

Progesterone

Drug

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.

Other names: Brand name: Utrogestan® 200 mg

placebo vaginal capsules

Drug

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

Primary outcomes

  1. Preterm delivery (before completed 37th week of gestation)

    Time frame: Assessed every 14 days until delivery or 36+6 weeks of gestation

Secondary outcomes

  1. Changes in uterine electromyographic (EMG) activity

    Time frame: Assessed every 14 days until delivery or 36+6 weeks of gestation

    EMG tracing will be analyzed using power density spectrum (PDS) and raw signal amplitude techniques to find mean PDS peak frequency and magnitude. Propagation velocity (PV) of uterine EMG signals will be determined from the time interval between signal arrivals at adjacent electrodes. Amplitude and duration of EMG burst plots will also be analyzed. The study groups will be compared with the PDS, PV and EMG burst plots to determine if progesterone alters the EMG in a way that is less likely to proceed toward labor and delivery.

  2. Cervical length changes

    Time frame: Assessed every 14 days until delivery or 36+6 weeks of gestation

    Cervical length will be measured by transvaginal ultrasound. The study groups will be compared to determine if progesterone alters the cervical shortening process.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • Slovenian Research Agency

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2012
Registry last updated
Apr 22, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.