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

This study is currently recruiting participants.
Verified November 2012 by University Medical Centre Ljubljana
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by (Responsible Party):
Ziva Novak Antolic, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01523483
First received: January 28, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Preterm Birth
 Drug: Progesterone
Drug: placebo vaginal capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Preterm delivery (before completed 37th week of gestation) [ Time Frame: Assessed every 14 days until delivery or 36+6 weeks of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in uterine electromyographic (EMG) activity [ Time Frame: Assessed every 14 days until delivery or 36+6 weeks of gestation ] [ Designated as safety issue: No ]
    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.

  • Cervical length changes [ Time Frame: Assessed every 14 days until delivery or 36+6 weeks of gestation ] [ Designated as safety issue: No ]
    Cervical length will be measured by transvaginal ultrasound. The study groups will be compared to determine if progesterone alters the cervical shortening process.


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progesterone
Patients in this arm will receive 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: 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.
Other Name: Brand name: Utrogestan® 200 mg
Placebo Comparator: placebo
Patients will receive two placebo capsules 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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523483

Contacts
Contact: Ziva Novak Antolic, PhD, MD 1 522 6004 ext +381 mihalucovnik@yahoo.com

Locations
Slovenia
Univerity Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Ziva Novak Antolic, PhD, MD     1 522 6004 ext + 386     mihalucovnik@yahoo.com    
Contact: Miha Lucovnik, MD     31 318 681 ext + 386     mihalucovnik@yahoo.com    
Principal Investigator: Ziva Novak Antolic, PhD, MD            
Sponsors and Collaborators
University Medical Centre Ljubljana
Slovenian Research Agency
Investigators
Principal Investigator: Ziva Novak Antolic, PhD, MD University Medical Centre Ljubljana
  More Information

Publications:

Responsible Party: Ziva Novak Antolic, prof. dr. Ziva Novak Antolic, MD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01523483     History of Changes
Other Study ID Numbers: P3-0124
Study First Received: January 28, 2012
Last Updated: November 14, 2012
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by University Medical Centre Ljubljana:
preterm birth
preterm labor
progesterone
uterine electromyography
cervical length

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications
Progesterone
 Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013