Clinical trial NCT01523483: Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor
Official title: Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: preterm birth
preterm labor
progesterone
uterine electromyography
cervical length
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency
First posted: 2012-02-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Preterm delivery (before completed 37th week of gestation)
timeFrame: Assessed every 14 days until delivery or 36+6 weeks of gestation
Secondary outcomes:
measure: Changes in uterine electromyographic (EMG) activity
timeFrame: Assessed every 14 days until delivery or 36+6 weeks of gestation
measure: Cervical length changes
timeFrame: Assessed every 14 days until delivery or 36+6 weeks of gestation
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Univerity Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Ziva Novak Antolic, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.