Plaquenil treatment of recurrent precnancy losses – a randomized, placebo controlled study

Phase 1

Conditions: Recurrent pregnancy losses. Women with >3 subsequent pregnancy losses or 3 pregnancy losses of which one was a 2. trimester loss.
MedDRA version: 19.1Level: LLTClassification code 10072314Term: Pregnancy lossSystem Organ Class: 100000004868
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2016-004981-24-DK

Lead Sponsor: Henriette Svarre Nielsen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 186

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

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 < 23 days or > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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. <br>;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. <br>

Secondary Outcome Measures

Name	Time	Method
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.<br><br>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.