Trial Outcomes & Findings for Coagulation Factor Changes Associated With Postpartum Hysterectomies (NCT NCT00456547)

Results Overview

Fibrinogen level decrease is a marker of consumptive coagulation which is is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases or stimulus. We hypothesized that women with excessive bleeding following delivery who require a hysterectomy are more likely to exhibit lower levels of fibrinogen and a consumptive coagulopathy than women following cesarean delivery who do not bleed.

Recruitment status

COMPLETED

Target enrollment

24 participants

Primary outcome timeframe

2 hours after delivery

Results posted on

2014-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Postpartum Hysterectomy Women that require postpartum hysterectomy for post-delivery bleeding.	Cesarean Delivery Case Controls Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coagulation Factor Changes Associated With Postpartum Hysterectomies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Postpartum Hysterectomy n=12 Participants Women that require postpartum hysterectomy for post-delivery bleeding.	Cesarean Delivery Case Controls n=12 Participants Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy	Total n=24 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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 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 United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours after delivery

Fibrinogen level decrease is a marker of consumptive coagulation which is is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases or stimulus. We hypothesized that women with excessive bleeding following delivery who require a hysterectomy are more likely to exhibit lower levels of fibrinogen and a consumptive coagulopathy than women following cesarean delivery who do not bleed.

Outcome measures

Outcome measures
Measure	Postpartum Hysterectomy n=12 Participants Women that require postpartum hysterectomy for post-delivery bleeding.	Cesarean Delivery Case Controls n=12 Participants Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
Fibrinogen Level at 2 Hours After Delivery	186 mg/dL Standard Deviation 80	418 mg/dL Standard Deviation 126

SECONDARY outcome

Timeframe: 2 hours after delivery

Platelets are decreased in subjects with consumptive coagulopathies which is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases. We hypothesized that women who require hysterectomy for postpartum bleeding are more likely to have decreased platelet counts than matched controls that underwent cesarean delivery.

Outcome measures

Outcome measures
Measure	Postpartum Hysterectomy n=12 Participants Women that require postpartum hysterectomy for post-delivery bleeding.	Cesarean Delivery Case Controls n=12 Participants Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
Platelet Counts at 2 Hours After Delivery	124 platelets (*1000 per liter) Standard Deviation 30	179 platelets (*1000 per liter) Standard Deviation 51

SECONDARY outcome

Timeframe: 2 hours after delivery

Plasminogen is converted to plasmin when the coagulation system is activated. We hypothesized that plasminogen should be decrease more in women with continued bleeding following delivery requiring hysterectomy will demonstrated a greater decrease in plasminogen than following cesarean delivery.

Outcome measures

Outcome measures
Measure	Postpartum Hysterectomy n=12 Participants Women that require postpartum hysterectomy for post-delivery bleeding.	Cesarean Delivery Case Controls n=12 Participants Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
Plasminogen Levels 2 Hours After Delivery	66 mg/dL Standard Deviation 22	108 mg/dL Standard Deviation 26

SECONDARY outcome

Timeframe: 2 hours after delivery

Antithrombin III is a glycoprotein and is the major inhibitor of thrombin and other activated clotting factors, including factors IX, X, XI, and XII, the cofactor through which heparin exerts its effect. We hypothesized that women with continued bleed following delivery and require a hysterectomy will demonstrate a greater reduction in antithrombin III that women undergoing cesarean delivery.

Outcome measures

Outcome measures
Measure	Postpartum Hysterectomy n=12 Participants Women that require postpartum hysterectomy for post-delivery bleeding.	Cesarean Delivery Case Controls n=12 Participants Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
Antithrombin III Levels at 2 Hours Post Delivery	51 percentage of normal antithrombin III Standard Deviation 22	89 percentage of normal antithrombin III Standard Deviation 18

Adverse Events

Postpartum Hysterectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cesarean Delivery Case Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert J McCarthy, Pharm D

Northwestern University Feinberg School of Medicine

Phone: 312-926-9015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place