Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

Sponsor

University of Colorado, Denver (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06141447

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D&E) in the clinic setting.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage	Drug: Oxytocin + normal saline Drug: Normal saline	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial - randomized to either receive treatment (40 units IV oxytocin + 1000 mL normal saline) or placebo (1000 mL normal saline alone).Randomized controlled trial - randomized to either receive treatment (40 units IV oxytocin + 1000 mL normal saline) or placebo (1000 mL normal saline alone).

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

This will be a double blinded study.

Primary Purpose:

Prevention

Official Title:

Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting

Anticipated Study Start Date :

Nov 20, 2023

Anticipated Primary Completion Date :

Jun 20, 2025

Anticipated Study Completion Date :

Jun 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxytocin Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D&E.	Drug: Oxytocin + normal saline 40 units IV oxytocin once in a 1000 mL bag of normal saline
Placebo Comparator: Placebo Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D&E.	Drug: Normal saline 1000 mL bag of normal saline alone

Arm

Intervention/Treatment

Experimental: Oxytocin

Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D&E.

Drug: Oxytocin + normal saline

40 units IV oxytocin once in a 1000 mL bag of normal saline

Placebo Comparator: Placebo

Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D&E.

Drug: Normal saline

1000 mL bag of normal saline alone

Outcome Measures

Primary Outcome Measures

Hemorrhage [day of procedure]
Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission
Quantitative blood loss [day of procedure]
Measured blood loss during procedure

Secondary Outcome Measures

Procedure time [day of procedure]
Length of time of total procedure and length of time until bleeding initially managed

Other Outcome Measures

Patient satisfaction and pain scores [day of procedure]
Patient satisfaction with procedure and maximum reported pain on a visual analog scale
Ease of procedure [day of procedure]
Provider reported ease of procedure
Rate of additional uterotonics [day of procedure]
Report of additional medications to treat bleeding used
Cost of additional uterotonics [day of procedure]
Estimated cost of additional uterotonics used

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

clinic-based D&E at 18 weeks gestational age and above
speaks English or Spanish

Exclusion Criteria:

refuses IV
history of coagulopathy
anticoagulant use in the preceding five days
chorioamnionitis or sepsis
suspected placenta accreta spectrum
intrauterine fetal demise
multiple gestation
use of misoprostol for cervical preparation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT06141447

Other Study ID Numbers:

23-2237

First Posted:

Nov 21, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hemorrhage

Oxytocin

Study Results

No Results Posted as of Nov 21, 2023