Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine

• Sponsor: University of South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT00858832
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can prolong the woman's stay in the hospital after birth, slow down her recovery time at home, and increase medical costs. Methergine is a medication that is routinely used to stop uterine hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery. Methergine works by contracting (tightening) the uterus. These contractions also help the uterus to expel or remove parts of the placenta that increase the chance of developing a uterine infection.

This research study is being done to learn if routine use of Methergine can lower the chances of developing a uterine infection after cesarean delivery. Half of the women in this study will receive Methergine for a few days during their hospitalization after cesarean delivery. The other half of the women will not routinely receive Methergine.

Condition or Disease	Intervention/Treatment	Phase
Endometritis	Drug: Methergine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methergine Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care.	Drug: Methergine; Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay
No Intervention: No treatment No treatment group received only routine postpartum care.

Outcome Measures

Primary Outcome Measures

1. Endometritis Incidence [One year]

   Number of participants who developed endometritis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Female singleton gravidas

2. Patients receiving non-elective cesarean deliveries after trial of labor

3. No evidence of chorioamnionitis

Exclusion Criteria:

1. Diagnosis of chorioamnionitis

2. Elective cesarean section

3. Unable to provide informed consent

4. Immunocompromised patients and those on antiretroviral drugs

5. Patients with known infection

6. Hypertension (blood pressure greater than 140/90 x 2, six hours apart), including those with a past history, gestational or Preeclampsia.

7. Allergic to ergot alkaloids. This would include people allergic to migraine medicine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa General Hospital	Tampa	Florida	United States	33602

Sponsors and Collaborators

• University of South Florida

Investigators

• Principal Investigator: Patrick Teefey, MD, Univeristy of South Florida OB/GYN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT00858832
• Other Study ID Numbers: 106202
• First Posted: Mar 10, 2009
• Last Update Posted: Sep 19, 2012
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Endometritis; Methylergonovine

Study Results

Participant Flow

Recruitment Details	Recruitment began 01dec2008 and was terminated 30apr2010. All recruitment was in a hospital.
Pre-assignment Detail	There were no washouts or run-ins. Patients were eligible upon the decision for a Cesarean delivery and then consented and randomized.

Arm/Group Title	Methergine	No Treatment
Arm/Group Description	Participants received Methergine 0.2mg orally every 6 hours for 2 days	Participants received no intervention (no treatment).
Period Title: Overall Study
STARTED	21	23
COMPLETED	20	22
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Methergine	No Methergine	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	21	23	44
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 100%	23 100%	44 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	21 100%	23 100%	44 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Endometritis Incidence
Description	Number of participants who developed endometritis
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methergine	No Methergine
Arm/Group Description
Measure Participants	21	23
Number [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Methergine		No Methergine
Arm/Group Description
All Cause Mortality
	Methergine		No Methergine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Methergine		No Methergine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Methergine		No Methergine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		1/23 (4.3%)
Pregnancy, puerperium and perinatal conditions
elevated blood pressure	0/21 (0%)		1/23 (4.3%)

Limitations/Caveats

Early termination due to lack of feasibility in completing project; full analysis was not conducted;

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.