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

Primary Purpose

Preterm Birth

Status

Completed

Phase

Not Applicable

Locations

Slovenia

Study Type

Interventional

Intervention

Progesterone

placebo vaginal capsules

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring preterm birth, preterm labor, progesterone, uterine electromyography, cervical length

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Univerity Medical Centre Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Progesterone

placebo

Arm Description

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.

Patients will receive two placebo capsules placed into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.

Outcomes

Primary Outcome Measures

Preterm delivery (before completed 37th week of gestation)

Secondary Outcome Measures

Changes in uterine electromyographic (EMG) activity

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

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

Full Information

NCT ID

NCT01523483

First Posted

January 28, 2012

Last Updated

April 21, 2015

Sponsor

University Medical Centre Ljubljana

Collaborators

Slovenian Research Agency

1. Study Identification

Unique Protocol Identification Number

NCT01523483

Brief Title

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

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Centre Ljubljana

Collaborators

Slovenian Research Agency

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Birth

Keywords

preterm birth, preterm labor, progesterone, uterine electromyography, cervical length

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Progesterone

Arm Type

Experimental

Arm Description

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Patients will receive two placebo capsules placed into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.

Intervention Type

Drug

Intervention Name(s)

Progesterone

Other Intervention Name(s)

Brand name: Utrogestan® 200 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo vaginal capsules

Intervention Description

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 Outcome Measure Information:

Title

Preterm delivery (before completed 37th week of gestation)

Time Frame

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

Secondary Outcome Measure Information:

Title

Changes in uterine electromyographic (EMG) activity

Description

Time Frame

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

Title

Cervical length changes

Description

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

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ziva Novak Antolic, PhD, MD

Organizational Affiliation

University Medical Centre Ljubljana

Official's Role

Principal Investigator

Facility Information:

Facility Name

Univerity Medical Centre Ljubljana

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

12. IPD Sharing Statement

Citations:

PubMed Identifier

21564026

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.

Results Reference

background

PubMed Identifier

21241260

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.

Results Reference

background

PubMed Identifier

21145033

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.

Results Reference

background

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

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