Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

nulliparous

singleton

age 18-45

spontaneous pregnancy or autologous assisted fertilization

Disqualifiers

coagulopathy

autoimmune diseases

gestational diabetes

anticoagulant therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • Hysterotomy closure

    Procedure/Surgery

    Hysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Single-layerExperimental treatment 1 intervention
Group B: Double-layerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intermenstrual bleeding reduction (days)

The primary outcome of the study is to evaluate weather there is a reduction of intermenstrual bleeding in the six months after cesarean section among the two groups of patients.

Time frame
6 months

Secondary outcomes

1

Intra-operatory time

Evaluate evaluate weather there is a difference in operative time among the two groups of patients

Time frame
6 months
2

Blood loss

Evaluate any difference in intra-operative blood loss (milliliters of blood)

Time frame
6 months
3

Analgesics

Evaluate any difference in post-operative use of analgesics

Time frame
6 months
4

Post-operatory recovery time

Evaluate any difference in post-operative recovery time (days)

Time frame
6 months

Other outcomes

Sponsors and contacts

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