NCT02144064

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
5.1 years until next milestone

Study Start

First participant enrolled

June 23, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 14, 2022

Status Verified

January 1, 2022

Enrollment Period

3.3 years

First QC Date

May 16, 2014

Last Update Submit

January 30, 2022

Conditions

Recurrent Pregnancy Loss

Keywords

Aspirin, heparin, pregnancy, recurrent pregnancy loss

Outcome Measures

Primary Outcomes (1)

  • 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 .

    during first 20 weeks of gregnancy

Secondary Outcomes (3)

  • Maternal outcomes

    during 40 weeks of pregnancy

  • prematurity

    after 20 weeks and before 37 weeks gestation

  • fetal outcome

    during last half of pregnancy(last 20 weeks)

Study Arms (2)

Group A(heparin group)

ACTIVE COMPARATOR

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

Drug: Heparin

Group B

NO INTERVENTION

group B (n = 100) receive no thing

Interventions

HeparinDRUG

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

Also known as: cal-heparin 5000 U, juspirin
Group A(heparin group)

Eligibility Criteria

Age21 Years - 46 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with unexplained recurrent pregnancy loss (RPL)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha univesity hospital

Banhā, El Qualyobia, 13518, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32358837DERIVED

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • khalid mohamed

    Department of Obstetrics and Gynecology, Benha University Hospital

    STUDY CHAIR

  • ahmed saad

    Benha University

    PRINCIPAL INVESTIGATOR

  • Ibrahim ali, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

khalid mohamed

CONTACT

201281469651dr.khalidkhader77@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of ob/gyn

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 21, 2014

Study Start

June 23, 2019

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

February 14, 2022

Record last verified: 2022-01

Locations

EG(1)