An interventional study of Gamimune N or Gamunex 10% and normal saline in Miscarriage, Recurrent and Abortion, Habitual, sponsored by University of Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2012-10-08.
Sponsored by University of Chicago · Not applicable, Interventional, and Treatment
Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are trying to establish a family. This clinical study will evaluate the effectiveness of intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from secondary recurrent miscarriage. This study will help in providing an answer to the question of whether IVIG is helpful in secondary recurrent miscarriage.
The purpose of this multi-center trial is to evaluate the efficacy of IVIG in improving the ongoing pregnancy (>20 weeks of gestation) rate in couples with unexplained secondary recurrent miscarriage, and; to characterize and compare pharmacokinetic and pharmacodynamic parameters for IVIG pre-conceptually and in the 1st and 2nd trimesters of pregnancy, so that an improved IVIG dosing strategy can be determined.
320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.
This study's enrollment of 82 is below the median of 147 across 174 interventional studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution
Biological: Gamimune N or Gamunex 10%
normal saline
Other: normal saline
500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
Also known as: Immune Globulin Intravenous (Human), 10%, IGIV-C, 10%
equivalent volume of normal saline
Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies
Time frame: 20 weeks gestation
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.
| Milestone | IVIG | Normal Saline |
|---|---|---|
| Started | 38 | 39 |
| Pregnancy | 29 | 33 |
| Completed | 23 | 24 |
| Not completed | 15 | 15 |
| Withdrew: No pregnancy | 9 | 6 |
| Withdrew: Non-index pregnancy | 1 | 4 |
| Withdrew: Withdrew | 5 | 5 |
| Successful pregnancies | IVIG | Normal Saline |
|---|---|---|
| Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies | 16 | 15 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IVIG | — | 0/23 (0%) | 9/23 (39.1%) |
| Normal Saline | — | 0/24 (0%) | 2/24 (8.3%) |
| Event | IVIG | Normal Saline |
|---|---|---|
| myalgia, headaches, nausea, fever or chillsGeneral disorders | 4/23 | 0/24 |
| rashSkin and subcutaneous tissue disorders | 3/23 | 0/24 |
| gastrointestinal symptomsGastrointestinal disorders | 0/23 | 2/24 |
| shortness of breathRespiratory, thoracic and mediastinal disorders | 1/23 | 0/24 |
| headacheGeneral disorders | 1/23 | 0/24 |
| Age Continuous(years) | IVIG | Normal Saline | Total |
|---|---|---|---|
| Mean | 36 ± 5 | 35 ± 4 | 36 ± 4 |
| Sex: Female, Male(Participants) | IVIG | Normal Saline | Total |
|---|---|---|---|
| Female | 23 | 24 | 47 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Chicago