NCT03296969

Brief Summary

We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years. The patients are divided randomly into two groups as follows:

  • Group (A): undergoing rectus muscle re-approximation
  • Group (B): not undergoing rectus muscle re-approximation

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

September 26, 2017

Last Update Submit

September 26, 2017

Conditions

Post Cesarean Section Pain

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    • Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4), patients are asked to read this list of adjectives and select the word that best describes their level of pain on the scale

    4 hours after operation

Study Arms (2)

rectus muscle approximation

ACTIVE COMPARATOR

All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide

Procedure: cesarean sectionProcedure: Rectus muscle approximation

rectus muscle non approximation

ACTIVE COMPARATOR

All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide

Procedure: cesarean section

Interventions

cesarean sectionPROCEDURE

All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide

rectus muscle approximationrectus muscle non approximation
Rectus muscle approximationPROCEDURE

aprroximation of the lower parts of rectus abdomius muscles during cesarean section

rectus muscle approximation

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primigravida
  • undergoing elective Cesarean section

You may not qualify if:

  • Patients with history of any pelvic or abdominal surgery those having any medical disorder with pregnancy patients with BMI ≥ 40 chronic analgesia use multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Ahmed Maged, MD

CONTACT

+20201005227404dr_ahmedmaged08@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

October 1, 2017

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

September 29, 2017

Record last verified: 2017-09