Trial Outcomes & Findings for Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage (NCT NCT00606905)

NCT ID: NCT00606905

Last Updated: 2012-10-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 82 participants
• Primary outcome timeframe: 20 weeks gestation
• Results posted on: 2012-10-08

Participant Flow

Between November 1999 and February 2008, a total of 82 women were recruited from seven centers: University of British Columbia, University of Chicago, University of Tennessee-Memphis, University of Toronto, Ottawa University, Yale University and McMaster University.

Five of the 82 withdrew consent prior to group assignment.

Participant milestones

Measure	IVIG IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.	Normal Saline equivalent volume of normal saline
Overall Study STARTED	38	39
Overall Study Pregnancy	29	33
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	15	15

Reasons for withdrawal

Measure	IVIG IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.	Normal Saline equivalent volume of normal saline
Overall Study No Pregnancy	9	6
Overall Study Non-Index Pregnancy	1	4
Overall Study Withdrew	5	5

Baseline Characteristics

Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage

Baseline characteristics by cohort

Measure	IVIG n=23 Participants IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.	Normal Saline n=24 Participants equivalent volume of normal saline	Total n=47 Participants Total of all reporting groups
Age Continuous	36 years STANDARD_DEVIATION 5 • n=5 Participants	35 years STANDARD_DEVIATION 4 • n=7 Participants	36 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 20 weeks gestation

Population: 47 women who achieved an index pregnancy, defined as the first pregnancy in the study, unless it resulted in a noneuploid miscarriage, ectopic, molar pregnancy or genetic termination, were analyzed.

Outcome measures

Measure	IVIG n=23 Participants IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.	Normal Saline n=24 Participants equivalent volume of normal saline
Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies	16 Successful pregnancies	15 Successful pregnancies

Adverse Events

IVIG

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IVIG n=23 participants at risk IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.	Normal Saline n=24 participants at risk equivalent volume of normal saline
General disorders myalgia, headaches, nausea, fever or chills	17.4% 4/23 • Number of events 5	0.00% 0/24
Respiratory, thoracic and mediastinal disorders shortness of breath	4.3% 1/23 • Number of events 1	0.00% 0/24
Gastrointestinal disorders gastrointestinal symptoms	0.00% 0/23	8.3% 2/24 • Number of events 2
Skin and subcutaneous tissue disorders rash	13.0% 3/23 • Number of events 3	0.00% 0/24
General disorders headache	4.3% 1/23 • Number of events 1	0.00% 0/24

Additional Information

Mary D. Stephenson, M.D. MSc

University of Chicago

Phone: 773 834-1167

Email: mstephen@babies.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place