NCT00259103

Brief Summary

The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

November 15, 2005

Last Update Submit

May 6, 2014

Conditions

Labor, Induced

Keywords

relaxinpregnancycervical ripeningnormal pregnancy at least at 40 weeks of gestation

Outcome Measures

Primary Outcomes (1)

  • Cervical ripening

    Through 24 hours

Secondary Outcomes (1)

  • Progression to active labor and delivery

    Within 7 Days of Drug Infusion

Study Arms (4)

7.5 µg/kg/d

EXPERIMENTAL

Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.

Drug: Serelaxin

25 µg/kg/d

EXPERIMENTAL

Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.

Drug: Serelaxin

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.

Drug: Serelaxin

Placebo

EXPERIMENTAL

Participants who received IV infusion of placebo, some during part A and others during part B.

Drug: Placebo

Interventions

SerelaxinDRUG
25 µg/kg/d7.5 µg/kg/d75 µg/kg/d
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 40 years
  • Normal pregnancy
  • At least 40 weeks of gestation
  • Otherwise healthy

You may not qualify if:

  • Anemia or hypertension
  • Presence of chronic disease
  • Endometriosis
  • Known fetal anomaly
  • Substance abuse
  • History of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novosibirsk State Medical Academy

Novosibirsk, Russia

Location

Evidence CPR

Saint Petersburg, 199034, Russia

Location

D.O. Ott Research Institute of Obstetrics and Gynecology

Saint Petersburg, Russia

Location

Related Publications (1)

  • 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.

    PMID: 27596360DERIVED

MeSH Terms

Interventions

serelaxin protein, human

Study Officials

  • Sam Teichman, MD

    Chief Medical Officer of BAS Medical, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 29, 2005

Study Start

November 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

RU(3)