Trial Outcomes & Findings for Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome (NCT NCT01051778)

Results Overview

Live birth occurs when a fetus (\> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

pregnancy > 24weeks gestation

Results posted on

2011-08-29

Participant Flow

This study was conducted between June 2006 to December 2009 at Cairo university hospital and Ahmed Elgazzar hospital ,Cairo.

Participant milestones

Participant milestones
Measure	Enoxaparin 40 mg /Day Plus Low Dose Aspirin	Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enoxaparin 40 mg /Day Plus Low Dose Aspirin n=30 Participants	Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin n=30 Participants	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	27.47 years STANDARD_DEVIATION 3.20 • n=5 Participants	28.57 years STANDARD_DEVIATION 3.48 • n=7 Participants	28.016 years STANDARD_DEVIATION 3.362 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Egypt	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: pregnancy > 24weeks gestation

Live birth occurs when a fetus (\> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord.

Outcome measures

Outcome measures
Measure	Enoxaparin 40 mg /Day Plus Low Dose Aspirin n=30 Participants	Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin n=30 Participants
Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)	24 Percentage of pregnancies	20 Percentage of pregnancies

SECONDARY outcome

Timeframe: Duration of pregnancy and puerperium

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of pregnancy and puerperium

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pregnancy > 20 weeks gestation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pregnancy >24 weeks gestation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks gestation<Pregnancy <37weeks gestation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of pregnancy and puerperium

Outcome measures

Outcome data not reported

Adverse Events

Enoxaparin 40 mg /Day Plus Low Dose Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Enoxaparin 40 mg /Day Plus Low Dose Aspirin n=30 participants at risk	Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin n=30 participants at risk
Reproductive system and breast disorders Severe bleeding episodes , e.g antepartum hemorrhage or postpartum hemorrhage	0.00% 0/30 • Number of events 30 • June 2006 to December 2009	0.00% 0/30 • Number of events 30 • June 2006 to December 2009

Additional Information

Usama .M .Fouda

Cairo university

Phone: +20123595106

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place