Skip to main content
OpenTrials
Completed

NCT Number: NCT01786330

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Neurologic Manifestations Obstetric Labor Complications Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases Uterine Hemorrhage

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kansas School of Medicine-Wichita, Wichita, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • bleeding disorder or use of anticoagulants other than low-dose heparin
  • abnormal placenta (placenta previa or accrete)
  • Preoperative hemoglobin less than 10 mg/dL
  • 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:
  • placenta accreta, increta, or percreta
  • vasa previa
  • cesarean hysterectomy required for severe hemorrhage
  • organ damage during cesarean (cystotomy, enterotomy, ureteral injury)

Treatment and study plan

Procare abdominal binder

Device

Standard of care

Other

Primary outcomes

  1. Lowest Pain Level Postoperative

    Time frame: 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.

  2. Average Pain Level Postoperative

    Time frame: 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.

  3. Worst Pain Level Postoperative

    Time frame: 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.

Secondary outcomes

  1. Change in Hemoglobin Concentration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zachary Kuhlmann, DO

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2013
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.