NCT02976311

Brief Summary

In this study, the investigators aimed to find out whether there are any differences in inflammatory reactions occured subsequent to two different cesarean delivery techniques; modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

November 22, 2016

Last Update Submit

November 24, 2016

Conditions

DeliveryCesarean DeliveryInflammation

Keywords

inflammatory reactionIL-6TNFMisgav Ladach techniquePfannenstiel-Kerr techniquecesarean deliverycesarean technique

Outcome Measures

Primary Outcomes (2)

  • IL-6

    percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery

    24 hours

  • TNF-alpha

    percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery

    24 hours

Study Arms (2)

Misgav-Ladach

ACTIVE COMPARATOR

cesarean section(C/S) via the modified 'Misgav-Ladach' technique

Procedure: cesarean section(C/S) via the modified Misgav-Ladach technique

Pfannenstiel-Kerr

ACTIVE COMPARATOR

cesarean section(C/S) via the 'Pfannenstiel-Kerr' technique

Procedure: cesarean section via the Pfannenstiel-Kerr technique

Interventions

cesarean section(C/S) via the modified Misgav-Ladach techniquePROCEDURE

the first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique

Misgav-Ladach
cesarean section via the Pfannenstiel-Kerr techniquePROCEDURE

the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique

Pfannenstiel-Kerr

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cesarean section for the first time
  • Term,singleton pregnancy

You may not qualify if:

  • Any inflammatory disease
  • Any pregnancy complication; IUGR,preeclampsia,preterm labor,preterm premature rupture of membranes
  • Pregnancies \<37weeks gestational age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 29, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

If needed