Recurrent pregnancy losses. Women with >3 subsequent pregnancy losses or 3 pregnancy losses of which one was a 2. trimester loss. MedDRA version: 19.1 Level: LLT Classification code 10072314 Term: Pregnancy loss System Organ Class: 100000004868
Conditions
Interventions
Trade Name: Plaquenil®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Hydroxychloroquine sulfate
CAS Number: 747-36-4
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Concentration unit: mg
Sponsors
Henriette Svarre Nielsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: >3 recurrent subsequent spontaneous pregnancy losses or 3 recurrent subsequent spontaneous pregnancy losses of which one is a second trimester loss. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 186 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Age below 18 or above 40 at the time of achieved pregnancy 2) Significant uterine abnormalities diagnosed by hysterosalpingography/hysteroscopy/hydrosonography. 3) Significant chromosome abnormalia (especially tranlocations) in the couple 4) Menstruation cycle 35 days 5) Lupusanticoagulans or IgG anticardiolipinantibody concentration =40 GPL kU/l or plasma homocystein =25 mikrogr./l after recurrent measurements with 8 weeks intervals before pregnancy 6) Positive test for HIV or tests suggestive på hepatitis B or C carrier state. 7) Psoriasis, retinopathy and adverse hearing loss (contra indications for Plaquenil) 8) Chronical diseases requiring anti inflammatory medicine or medicine potentially harmfull to pregnancy: corticosteroids, acetylsalicyle acid, indometacin, simvastatin, imurel ect.. Periodic paracetamol use is allowed. 9) >1 previous live birth 10) Previous participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Weight at birth, duration of pregnancy, Apgar-score 5 minutes after delivery and the amount of days at neonatal department in the Plaquenil versus the placebo group. The immunological status (cytokine profile) in the women who obtains a live birth compared with the women with another pregnancy loss as well as in the women in the Plaquenil group compared with the placebo group. ;Primary end point(s): Chance of live birth in women with unexplained recurrent pregnancy losses in women treated with Plaquenil compared with placebo. ;Timepoint(s) of evaluation of this end point: When trial is completed - 186 patients included and they all have either a live birth or another pregnancy loss.;Main Objective: The objective of the trial is to investigate whether Plaquenil (Hydroxychloroquin sulfate) prior to and during pregnancy increases the chance of live birth in women with unexplained recurrent pregnancy losses compared with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Weight at birth, duration of pregnancy, Apgar-score 5 minutes after delivery and the amount of days at neonatal department in the Plaquenil versus the placebo group. The immunological status (cytokine profile) in the women who obtains a live birth compared with the women with another pregnancy loss as well as in the women in the Plaquenil group compared with the placebo group. ;Timepoint(s) of evaluation of this end point: When trial is completed - 186 patients included and they all have either a live birth or another pregnancy loss. | — |
Countries
Denmark
Contacts
Public ContactHenriette Svarre Nielsen
Henriette Svarre Nielsen
Outcome results
None listed