Trial Outcomes & Findings for Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery (NCT NCT06118957)

NCT ID: NCT06118957

Last Updated: 2025-09-04

Results Overview

Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks
• Results posted on: 2025-09-04

Participant Flow

Participant milestones

Measure	Experimental: Enoxaparin Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days	No Intervention: No Treatment Participants will receive no enoxaparin treatment.
Overall Study STARTED	32	32
Overall Study COMPLETED	32	29
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

Baseline characteristics by cohort

Measure	Enrolled n=64 Participants Participants who enrolled in the study	Declined n=547 Participants Patients who declined participation in the study	Total n=611 Participants Total of all reporting groups
Age, Continuous	30.95 years of age STANDARD_DEVIATION 5.5 • n=5 Participants	31.37 years of age STANDARD_DEVIATION 5.7 • n=7 Participants	31.32 years of age STANDARD_DEVIATION 5.66 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	547 Participants n=7 Participants	611 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	156 Participants n=7 Participants	170 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	315 Participants n=7 Participants	355 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	76 Participants n=7 Participants	86 Participants n=5 Participants

PRIMARY outcome

Timeframe: A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks

Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures

Outcome measures

Measure	Eligible Participants n=694 Participants Eligible Participants for Enrollment in the Study	No Treatment Participants will receive no enoxaparin treatment.
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures # of eligible patients	694 participants	—
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures Approach rate (proportion of eligible patients approached)	611 participants	—
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures Enrollment rate (proportion of eligible patients enrolled)	64 participants	—
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures Retention rate (proportion enrolled completing study)	61 participants	—

SECONDARY outcome

Timeframe: 6 Weeks

Population: There were no reported incidents for venous thromboembolism

Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism

Outcome measures

Measure	Eligible Participants n=32 Participants Eligible Participants for Enrollment in the Study	No Treatment n=32 Participants Participants will receive no enoxaparin treatment.
Rate of Venous Thromboembolism	0 # of venous thromboembolism events	0 # of venous thromboembolism events

SECONDARY outcome

Timeframe: 6 Weeks

Clinically diagnosed

Outcome measures

Measure	Eligible Participants n=32 Participants Eligible Participants for Enrollment in the Study	No Treatment n=32 Participants Participants will receive no enoxaparin treatment.
Rate of Wound Hematoma or Infection	2 # of reported wound hematoma events	1 # of reported wound hematoma events

SECONDARY outcome

Timeframe: 6 Weeks

Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (>24 hours after delivery)

Outcome measures

Measure	Eligible Participants n=32 Participants Eligible Participants for Enrollment in the Study	No Treatment n=32 Participants Participants will receive no enoxaparin treatment.
Rate of Bleeding Complications	0 # of reported bleeding complication even	1 # of reported bleeding complication even

Adverse Events

Enoxaparin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

No Treatment-

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enoxaparin n=32 participants at risk Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days. Enoxaparin: Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.	No Treatment- n=32 participants at risk Participants will receive no enoxaparin treatment.
Pregnancy, puerperium and perinatal conditions Blood in Breast Milk	3.1% 1/32 • Number of events 1 • Within 6 Weeks Postpartum Complications by study group	0.00% 0/32 • Within 6 Weeks Postpartum Complications by study group
Gastrointestinal disorders cholelithiasis	0.00% 0/32 • Within 6 Weeks Postpartum Complications by study group	3.1% 1/32 • Number of events 1 • Within 6 Weeks Postpartum Complications by study group
Infections and infestations Cellulitis	3.1% 1/32 • Number of events 1 • Within 6 Weeks Postpartum Complications by study group	0.00% 0/32 • Within 6 Weeks Postpartum Complications by study group
Pregnancy, puerperium and perinatal conditions Uterine Rupture with broad ligament hematoma	0.00% 0/32 • Within 6 Weeks Postpartum Complications by study group	3.1% 1/32 • Number of events 1 • Within 6 Weeks Postpartum Complications by study group
Infections and infestations Surgical site infection	3.1% 1/32 • Number of events 1 • Within 6 Weeks Postpartum Complications by study group	0.00% 0/32 • Within 6 Weeks Postpartum Complications by study group
Pregnancy, puerperium and perinatal conditions Superficial incision separation	3.1% 1/32 • Number of events 1 • Within 6 Weeks Postpartum Complications by study group	0.00% 0/32 • Within 6 Weeks Postpartum Complications by study group
Gastrointestinal disorders Pancreatitis	0.00% 0/32 • Within 6 Weeks Postpartum Complications by study group	3.1% 1/32 • Number of events 1 • Within 6 Weeks Postpartum Complications by study group

Additional Information

Elizabeth Turner, MPH, Senior Regulatory Coordinator

University of Utah Obgyn

Phone: 8012018929

Email: elizabeth.e.turner@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place