| July 23, 2008 |
| February 17, 2009 |
| August 2008 |
| June 2011 (final data collection date for primary outcome measure) |
| The difference in the subsequent livebirth rate among patients with secondary recurrent miscarriage who, during the trial, receive intravenous immunoglobulin or placebo, respectively, without any exclusions (ITT analysis) [ Time Frame: August 2008 to June 2011 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00722475 on ClinicalTrials.gov Archive Site |
| The difference in the subsequent livebirth rate among women with secondary recurrent miscarriage who receive intravenous immunoglobulin or placebo, respectively, after relevant and predefined exclusions (PP analysis). [ Time Frame: August 2008 to June 2011 ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage |
| A Randomized, Placebo-Controlled, Double-Blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage |
The investigators want to test whether infusions of intravenous immunoglobulin - a blood product known to modify immune responses - in early pregnancy will increase the chance of a subsequent live birth in women with three or more miscarriages after a birth and a total of at least four miscarriages. This will be done in a trial where 82 patients will be randomly allocated to infusions with intravenous immunoglobulin or placebo during pregnancy. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Secondary Recurrent Miscarriage |
- Drug: Intravenous immunoglobulin
- Drug: Human albumin
|
- Experimental: Repeated infusions of intravenous immunoglobulin in early pregnancy
- Placebo Comparator: infusion of human albumin
|
- Hutton B, Sharma R, Fergusson D, Tinmouth A, Hebert P, Jamieson J, Walker M. Use of intravenous immunoglobulin for treatment of recurrent miscarriage: a systematic review. BJOG. 2007 Feb;114(2):134-42. Epub 2006 Dec 12. Review.
- Christiansen OB, Pedersen B, Rosgaard A, Husth M. A randomized, double-blind, placebo-controlled trial of intravenous immunoglobulin in the prevention of recurrent miscarriage: evidence for a therapeutic effect in women with secondary recurrent miscarriage. Hum Reprod. 2002 Mar;17(3):809-16.
- Christiansen OB, Mathiesen O, Lauritsen JG, Grunnet N. Intravenous immunoglobulin treatment of women with multiple miscarriages. Hum Reprod. 1992 May;7(5):718-22.
- Christiansen OB, Mathiesen O, Husth M, Rasmussen KL, Ingerslev HJ, Lauritsen JG, Grunnet N. Placebo-controlled trial of treatment of unexplained secondary recurrent spontaneous abortions and recurrent late spontaneous abortions with i.v. immunoglobulin. Hum Reprod. 1995 Oct;10(10):2690-5.
|
| |
| Recruiting |
| 82 |
| November 2011 |
| June 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 4 or more miscarriages before the end of gestational week 14 in patients with secondary recurrent miscarriages.
- At least three of these must be consecutive after the previous birth
- At least three of the miscarriages with the present partner.
Exclusion Criteria:
- Age below 18 or above 41 years at conception
- Significant uterine anomalies detected by hysterosalpingography, hysteroscopy or hydrosonography.
- Significant chromosomal aberrations in the couple
- Menstrual cycle < 23 or > 35 days
- Presence of lupus anticoagulant or IgG anticardiolipin concentration >= 40 GPL ku/l or plasma homocystein >= 25 microg./l by repeated measurements at 8 weeks intervals
- Tests positive for HIV or tests indicating carriage of hepatitis B or C
- IgA deficiency
- Allergy to albumin, IvIg or one of the substances added to preserve the drugs.
- Presence of chronic disease, which necessitate permanent treatment with e.g. corticosteroids , non-steroidal antiinflammatory drugs, anticoagulation, simvastatin or imurel from the start of pregnancy.
- Less than 3 of the previous pregnancy losses documented by ultrasound or uterine curettage.
- Present pregnancy a result of donor insemination or egg donation.
- Planned administration of gestagens or estrogens from the beginning of pregnancy.
- 3 or more previous IVF/ICSI/FER attempts without pregnancy or resulting in chemical pregnancy/miscarriage.
- Previous participation in the trial.
|
| Female |
| 18 Years to 40 Years |
| No |
| Contact: Ole B. Christiansen, MD, D.M.Sc. |
+45 35458486 |
rh08636@rh.dk |
|
|
| Denmark |
| |
| NCT00722475 |
| Ole Bjarne Christiansen, Rigshospitalet |
| IvIg for recurrent miscarriage, EudraCT nr. 2008-001589-94 |
| Rigshospitalet, Denmark |
| The Ministry of Science, Technology and Innovation, Denmark |
| Principal Investigator: |
Ole B. Christiansen, MD, D.M.Sc. |
Rigshospitalet, Denmark |
|
|
| Rigshospitalet, Denmark |
| February 2009 |