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

Primary Purpose

Recurrent Pregnancy Loss

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Heparin
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Pregnancy Loss focused on measuring Aspirin, heparin, pregnancy, recurrent pregnancy loss

Eligibility Criteria

21 Years - 46 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Benha univesity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group A(heparin group)

Group B

Arm Description

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

group B (n = 100) receive no thing

Outcomes

Primary Outcome Measures

pregnancy loss
evidence of abortion is assessed clinically by vaginal bleeding and passage of contents of conception through vagina or by ultrasound through detecting missed abortion .

Secondary Outcome Measures

Maternal outcomes
Maternal 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
prematurity
delivery of babies before fetal maturity which necessitate admission to the neonatal unit
fetal outcome
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

Full Information

First Posted
May 16, 2014
Last Updated
January 30, 2022
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT02144064
Brief Title
Pregnancy Outcomes in Women With Unexplained Recurrent Pregnancy Loss Treated With Low Dose Aspirin and Unfractionated Heparin
Official Title
Pregnancy Outcomes in Women With Unexplained Recurrent Pregnancy Loss Treated With Low Dose Aspirin and Unfractionated Heparin
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pregnancy Loss
Keywords
Aspirin, heparin, pregnancy, recurrent pregnancy loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A(heparin group)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B
Arm Type
No Intervention
Arm Description
group B (n = 100) receive no thing
Intervention Type
Drug
Intervention Name(s)
Heparin
Other Intervention Name(s)
cal-heparin 5000 U, juspirin
Intervention Description
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
Primary Outcome Measure Information:
Title
pregnancy loss
Description
evidence of abortion is assessed clinically by vaginal bleeding and passage of contents of conception through vagina or by ultrasound through detecting missed abortion .
Time Frame
during first 20 weeks of gregnancy
Secondary Outcome Measure Information:
Title
Maternal outcomes
Description
Maternal 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
Time Frame
during 40 weeks of pregnancy
Title
prematurity
Description
delivery of babies before fetal maturity which necessitate admission to the neonatal unit
Time Frame
after 20 weeks and before 37 weeks gestation
Title
fetal outcome
Description
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
Time Frame
during last half of pregnancy(last 20 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
khalid mohamed
Phone
201281469651
Email
dr.khalidkhader77@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khalid mohamed
Organizational Affiliation
Department of Obstetrics and Gynecology, Benha University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ahmed saad
Organizational Affiliation
Benha faculty of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ibrahim ali, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benha univesity hospital
City
Banhā
State/Province
El Qualyobia
ZIP/Postal Code
13518
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
khalid mohamed
Phone
201281469651
Email
dr.khalidkhader77@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32358837
Citation
Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
Results Reference
derived

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

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