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Pregnancy Outcomes in Women With Unexplained Recurrent Pregnancy Loss Treated With Low Dose Aspirin and Unfractionated Heparin

Pregnancy Outcomes in Women With Unexplained Recurrent Pregnancy Loss Treated With Low Dose Aspirin and Unfractionated Heparin

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02144064
Enrollment
200
Registered
2014-05-21
Start date
2019-06-23
Completion date
2022-12-31
Last updated
2022-02-14

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

Conditions

Recurrent Pregnancy Loss

Keywords

Aspirin, heparin, pregnancy, recurrent pregnancy loss

Brief summary

Objective To determine maternal and fetal outcomes in women with Unexplained RPL managed with aspirin or unfractionated heparin (UFH) plus aspirin during pregnancy. Design: prospective clinical controlled study. Setting: high-risk pregnancy unit- Benha university hospital. Methods: Pregnant women with unexplained recurrent miscarriage attending high-risk pregnancy unit. 200 selected patients with previous unexplained recurrent miscarriage are divided into 2 groups: group A (n = 100) receive low-dose aspirin (81 mg once daily orally) plus heparin (5000 IU) every 12 h with the first positive pregnancy test while group B (n = 100) receive no thing . Main outcome measures: Maternal outcomes included thromboembolic and haemorrhagic complications and pregnancy-induced hypertension .Prematurity, intrauterine growth restriction and neonatal death were considered as maternal and fetal complications

Detailed description

This prospective comparative, controlled clinical study is conducted at Department of Obstetrics and Gynecology, Benha University Hospital, and a private center, from June 2012 . After approval of the study protocol by the Local Ethical Committee and obtaining written fully informed patients' consents. All patients are interviewed about their medical, personal, family, obstetrical and thrombosis history. All patients included in study complain of three or more unexplained consecutive spontaneous abortions. All patients (n=200) are in good general health without previous history of Diabetes Mellitus or thyroid dysfunction or cardiac disease. Patients with Thrombocytopenia (\<100000/ml), bleeding tendencies, ectopic pregnancy, past history of vascular thrombosis ,uterine anomalies and multiple gestation are excluded from the study. complete blood picture, urine routine examination, blood sugar, blood grouping, Bleeding Time, Clotting Time, Prothrombin Time, Activated Partial Thromboplastin Time, Hepatitis B Surface Ag, Hepatitis C Virus screening are offered to all patients and findings noted as soon as they conceived. All patients are given routine Folic Acid, Iron and Calcium supplementation orally daily during antenatal period (whether conceived spontaneously or with treatment 200 selected patients with previous unexplained recurrent pregnancy loss are divided into 2 groups:Group A (n = 100) are put on Inj. UFH (Cal-heparin) 5000 U subcutaneous twice daily plus Aspirin 81 mg/day (Juspirin) with the first positive pregnancy test, Inj. UFH is given either into anterior abdominal wall or anterior aspect of thigh subcutaneously. While group B (n = 100) receive no thing

Interventions

DRUGHeparin

Group A (n = 100) are put on Inj. UFH (Cal-heparin) 5000 U subcutaneous twice daily plusAspirin 81 mg/day (Juspirin) with the first positive pregnancy test, Inj. UFH is given either into anterior abdominal wall or anterior aspect of thigh subcutaneously

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 46 Years
Healthy volunteers
No

Inclusion criteria

* patients with unexplained recurrent pregnancy loss (RPL)

Exclusion criteria

* previous history of Diabetes Mellitus or thyroid dysfunction or cardiac disease * Thrombocytopenia (\<100000/ml) * bleeding tendencies * ectopic pregnancy * past history of vascular thrombosis * uterine anomalies * multiple gestation

Design outcomes

Primary

MeasureTime frameDescription
pregnancy lossduring first 20 weeks of gregnancyevidence of abortion is assessed clinically by vaginal bleeding and passage of contents of conception through vagina or by ultrasound through detecting missed abortion .

Secondary

MeasureTime frameDescription
Maternal outcomesduring 40 weeks of pregnancyMaternal outcomes include thromboembolic and hemorrhagic complications and pregnancy-induced hypertension.these outcomes is assessed clinically by follow up mother throughout pregnancy e.g frequent blood pressure monitoring
prematurityafter 20 weeks and before 37 weeks gestationdelivery of babies before fetal maturity which necessitate admission to the neonatal unit
fetal outcomeduring last half of pregnancy(last 20 weeks)Foetal growth is monitored by fundal height measurement and serial ultrasounds. Doppler umbilical wave flow velocity is studied for foetuses with suspected intrauterine growth retardation

Countries

Egypt

Contacts

Primary Contactkhalid mohamed
dr.khalidkhader77@yahoo.com201281469651

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026