NCT03009955

Brief Summary

To everyone knows, more and more patients received repeated caesarean section in China. However, at present it is not known what is it like about their postoperative pain intensity, and is it different from those patients who received primary caesarean section. Thus through postoperative follow-up, the current study aimed to investigate and compare the postoperative pain between patients received primary and repeated caesarean section.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

December 30, 2016

Last Update Submit

July 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery

    At 4, 8, 12, 24 and 48 hours after the surgery

Secondary Outcomes (2)

  • Pain intensity at 3 to 7 days after the surgery

    At 3 to 7 days after the surgery

  • Pain intensity at 4 weeks after the surgery

    At 4 weeks after the surgery

Study Arms (2)

Group P

patients who received primary caesarean section

Group R

patients who received repeated caesarean section

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who receiving primary and repeated caesarean section.

You may qualify if:

  • single birth
  • full-term pregnancy
  • in accordance with cesarean section indications
  • transverse incision of lower uterine segment

You may not qualify if:

  • history of dementia, psychiatric illness or any diseases of central nervous system
  • accompanying liver or kidney function deficiency
  • alcoholism and drug dependence
  • patients previously included in this study or currently included in the other clinical study
  • patients who have second surgery during the study period
  • difficult to follow up or patients with poor compliance
  • history of chronic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinqiao Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Related Publications (1)

  • Duan G, Yang G, Peng J, Duan Z, Li J, Tang X, Li H. Comparison of postoperative pain between patients who underwent primary and repeated cesarean section: a prospective cohort study. BMC Anesthesiol. 2019 Oct 22;19(1):189. doi: 10.1186/s12871-019-0865-9.

Study Officials

  • Hong Li, M.D.

    Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Anesthesiology

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 4, 2017

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

July 6, 2017

Record last verified: 2017-07

Locations