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

Information source: University Medical Centre Ljubljana
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Birth

Intervention: Progesterone (Drug); placebo vaginal capsules (Drug)

Phase: N/A

Status: Completed

Sponsored by: University Medical Centre Ljubljana

Official(s) and/or principal investigator(s):
Ziva Novak Antolic, PhD, MD, Principal Investigator, Affiliation: University Medical Centre Ljubljana

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.

Clinical Details

Official title: Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Preterm delivery (before completed 37th week of gestation)

Secondary outcome:

Changes in uterine electromyographic (EMG) activity

Cervical length changes

Eligibility

Minimum age: 18 Years. Maximum age: 48 Years. Gender(s): Female.

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.

Locations and Contacts

Univerity Medical Centre Ljubljana, Ljubljana 1000, Slovenia
Additional Information

Related publications:

Lucovnik M, Kuon RJ, Chambliss LR, Maner WL, Shi SQ, Shi L, Balducci J, Garfield RE. Progestin treatment for the prevention of preterm birth. Acta Obstet Gynecol Scand. 2011 Oct;90(10):1057-69. doi: 10.1111/j.1600-0412.2011.01178.x. Epub 2011 Jun 27. Review.

Lucovnik M, Kuon RJ, Chambliss LR, Maner WL, Shi SQ, Shi L, Balducci J, Garfield RE. Use of uterine electromyography to diagnose term and preterm labor. Acta Obstet Gynecol Scand. 2011 Feb;90(2):150-7. doi: 10.1111/j.1600-0412.2010.01031.x. Epub 2010 Dec 7. Review.

Lucovnik M, Maner WL, Chambliss LR, Blumrick R, Balducci J, Novak-Antolic Z, Garfield RE. Noninvasive uterine electromyography for prediction of preterm delivery. Am J Obstet Gynecol. 2011 Mar;204(3):228.e1-10. doi: 10.1016/j.ajog.2010.09.024. Epub 2010 Dec 8.

Starting date: March 2012
Last updated: April 21, 2015

Page last updated: August 23, 2015

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