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The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.
A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7.5 µg/kg/d | Experimental | Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A. |
|
| 25 µg/kg/d | Experimental | Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A. |
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| 75 µg/kg/d | Experimental | Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B. |
|
| Placebo | Experimental | Participants who received IV infusion of placebo, some during part A and others during part B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serelaxin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical ripening | Through 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Progression to active labor and delivery | Within 7 Days of Drug Infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Teichman, MD | Chief Medical Officer of BAS Medical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk State Medical Academy | Novosibirsk | Russia | ||||
| Evidence CPR |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27596360 | Derived | Weiss G, Teichman S, Stewart D, Nader D, Wood S, Breining P, Unemori E. Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour. BMC Pregnancy Childbirth. 2016 Sep 5;16(1):260. doi: 10.1186/s12884-016-1046-1. |
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| ID | Term |
|---|---|
| C577649 | serelaxin protein, human |
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| Drug |
|
| Saint Petersburg |
| 199034 |
| Russia |
| D.O. Ott Research Institute of Obstetrics and Gynecology | Saint Petersburg | Russia |