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| Name | Class |
|---|---|
| Slovenian Research Agency | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone | Experimental | 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. |
|
| placebo | Placebo Comparator | Patients will receive two placebo capsules placed into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm delivery (before completed 37th week of gestation) | Assessed every 14 days until delivery or 36+6 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziva Novak Antolic, PhD, MD | University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerity Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21564026 | Background | 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. | |
| 21241260 | Background | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| 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. |
|
| Assessed every 14 days until delivery or 36+6 weeks of gestation |
| 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. | Assessed every 14 days until delivery or 36+6 weeks of gestation |
| 21145033 | Background | 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |