NCT03968783

Brief Summary

We want to compare the effects of 2 suture materials (monofilament and multifilament) on healing of the uterine scar after a cesarean delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

May 28, 2019

Last Update Submit

February 10, 2020

Conditions

Wound HealCesarean Section ComplicationsCesarean Wound DisruptionSuture Related Complication

Keywords

cesarean sectionscar healisthmocelesuture materialsaline infusion sonography

Outcome Measures

Primary Outcomes (1)

  • The healing ratio

    Six months after the operation, the integrity of the cesarean scar at the uterine incision site will be assessed by hydrosonography. The healing ratio will be calculated as the thickness of the residual myometrium covering the defect, divided by the sum of the thickness of the residual myometrium covering the defect and the height of the wedge-shaped defect.

    6 months

Secondary Outcomes (2)

  • blood loss

    24 hours

  • additional sutures

    2 hours

Study Arms (2)

Monofilament suture

EXPERIMENTAL

continuous double-layer unlocked suturing with 1.0 monofilament synthetic absorbable suture

Other: Monofilament suture

Multifilament suture

ACTIVE COMPARATOR

continuous double-layer unlocked suturing with 1.0 multifilament synthetic absorbable suture

Other: Multifilament suture

Interventions

Monofilament sutureOTHER

1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision

Monofilament suture
Multifilament sutureOTHER

1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision

Multifilament suture

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy at term \>37 weeks of gestational age

You may not qualify if:

  • history of previous cesarean section
  • history of previous uterine surgery
  • multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
  • uterine atony history
  • gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
  • active labor (with regular uterine contractions and cervical dilatation \>4 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University Hospital

Istanbul, 34093, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

May 30, 2019

Study Start

May 27, 2019

Primary Completion

July 27, 2019

Study Completion

January 27, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

TU(1)