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The effect of Prednisolone in reducing of recurrent abortion

A randomized controlled trial of prednisolone for women with idiopathic recurrent miscarriage and raised levels of Peripheral natural killer cells .

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013110915342N1
Enrollment
100
Registered
2014-05-12
Start date
2013-11-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Recurrent Abortion. Miscarriage

Interventions

Intervention 1: Case group are treated with prednisolone with this protocol: prednisolone 2 months before taking action to pregnancy
first week 20 mg daily
second week 15 mg daily
third to seventh week 10 mg daily
eighth week 5 mg daily.Then recheck NK-cell density , if there is suitable response, taking action to pregnancy will be allowed .After positive pregnancy test ,restarting prednisolone or placebo with
with this protocol: placebo 2 months before taking action to pregnancy
eighth week 5 mg daily.Then recheck NK-cell density , if there is suitable response, taking action to pregnancy will be allowed .After positive pregnancy test ,restarting placebo with this protocol:10
Treatment - Drugs
Case group are treated with prednisolone with this protocol: prednisolone 2 months before taking action to pregnancy
Control group with placebo before and during pregnancy

Sponsors

Avicenna Research Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: female gender; being a case of idiopathic abortion; in flow cytometry of peripheral blood, CD56 more than 12 or CD 16/56 more than 8. Exclusion criteria: age less than 20 or more than 40 years old; having less than 2 abortions; history of abortion more than 20w of gestational age; uterine disorder; chromosomal disorder in couples; antiphospholipid syndrome; contraindication of corticosteroid; abnormal thyroid function test result.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Abortion. Timepoint: 12th and 20th weeks of gestation. Method of measurement: Patients file.;Live birth. Timepoint: After Birth. Method of measurement: Patient file.

Secondary

MeasureTime frame
Peripheral Natural Killer Cell. Timepoint: Before intervention, 2 months after intervention, 8th, 12th, 20th weeks of gestation. Method of measurement: Flow cytometry.;Chemical pregnancy. Timepoint: 1 week after retardation of mens. Method of measurement: Positive beta-hcg test.;Pre eclampsia. Timepoint: After 20th week of gestation. Method of measurement: Blood pressure measuring.;Drug Complications. Timepoint: After Treatment. Method of measurement: Patients files.;Gestational Diabetes. Timepoint: After 20th week of gestation. Method of measurement: FBS, GCT, GTT.;IUGR. Timepoint: After 28th week of gestation. Method of measurement: Obstetrical ultrasound scan.;Clinical Pregnancy. Timepoint: After 5-6 th week of gestation. Method of measurement: Obstetrical Ultra Sound Scan.;Ongoing Pregnancy. Timepoint: After 7th week. Method of measurement: Obstetrical Ultrasound Scan.;Gestational age at delivery. Timepoint: After 24th week of gestation. Method of measurement: Patient file.;Feotal Abnormality. Timepoint: At 20th weeks gestation. Method of measurement: Anomaly Ultrasound Scan.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Rashin Zargham

Avicenna Infertility and Recurrent Aborsion Center

r.zargham@avicenna.ac.ir; zargham_dr@yahoo.com+98 21 23519

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026