Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

Not Applicable

Completed

• Conditions: Pain; Postpartum Hemorrhage

• Registration Number: NCT01786330
• Lead Sponsor: Zachary Kuhlmann, DO

Brief Summary

This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2016-02-09
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-10
• Last Update Submitted: 2016-03-10
• Results First Posted: 2016-04-11
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Cesarean section at term (at least 39 weeks gestation) scheduled in advance

• Singleton gestation confirmed by ultrasound in the current pregnancy

• Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)

• None of these pregnancy complications in the current pregnancy:

  1. bleeding disorder or use of anticoagulants other than low-dose heparin
  2. abnormal placenta (placenta previa or accrete)
  3. Preoperative hemoglobin less than 10 mg/dL
  4. Chorioamnionitis (intrauterine infection)

• No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)

• Able to read English and understand spoken English

Exclusion Criteria

• Onset of labor prior to time when the cesarean was scheduled

• Complications during performance of cesarean or discovered during cesarean:

  1. placenta accreta, increta, or percreta
  2. vasa previa
  3. cesarean hysterectomy required for severe hemorrhage
  4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average Pain Level Postoperative	24 hours postoperative	SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.
Worst Pain Level Postoperative	24 hours postoperative	SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.
Lowest Pain Level Postoperative	24 hours postoperative	SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin Concentration	24 hours from baseline	Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.

Trial Locations

Locations (2)

Kansas School of Medicine-Wichita; 🇺🇸 Wichita, Kansas, United States

Wesley Medical Center; 🇺🇸 Wichita, Kansas, United States