Primary objective: to study the (cost) effectiveness of double layer closure of the uterine scar after a caesarean delivery, in comparison to single layer closure, in the prevention of niche development and related menstrual spotting.Secondary…
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: post- and intermenstrual spotting 9 months after
randomization.
Secondary outcome
Secondary outcome: menstrual pattern (score card) and dysmenorhoe (VAS),
Quality of life (SF36 & EQ-5D-5L), societal reintegration (PROMIS), sexual
function (FSFI), Niche (characteristics), complications, surgery time and
costs, % of ongoing pregnancies, life birth rate and time to conceive in women
willing to conceive.
Background summary
Double layer compared to single layer closure of the uterus after a caesarean
section (CS) leads to a thicker myometrial layer at the site of the CS scar
(residual myometrium) and possibly decreases the development of niches. A niche
is a CS defect at the site of the uterine scar and is associated with
gynaecological symptoms including postmenstrual spotting (OR 3.1 (1.5 - 6.3)).
It is also associated with failure of trail of labour after CS and possibly
with subfertility. In the Netherlands single layer closure of the uterus is
performed by 92% of the gynaecologists.
Hypothesis: Double layer closure of the uterine scar using unlocked continuous
running sutures reduces menstrual disorders and pain and subfertility in
relation to niche development and increases QOL and improves sexual
functioning.
Study objective
Primary objective: to study the (cost) effectiveness of double layer closure of
the uterine scar after a caesarean delivery, in comparison to single layer
closure, in the prevention of niche development and related menstrual spotting.
Secondary objectives: to assess the effect of the intervention on quality of
life, societal participation, sexual function and on niche development and on
subfertility and societal costs.
Study design
Multicentre randomised controlled trial (superiority). Patients and ultrasound
examiners will be blinded for allocation. Cost effectiveness analysis form a
societal perspective alongside the trial.
Intervention
Double layer closure (unlocked) continuous running suture of the uterus using
multifilament material (instructed by e-learning) compared with usual (single
layer) closure of the uterus, using a continuous running multifilament suture.
Study burden and risks
Double layer closure requires only little efforts of care providers in
comparison to usual provided care (mean time investment of 6 minutes to execute
the double layer suturing instead of single layer suturing). There are no
negative effects on short term outcomes and double layer closure may result in
positive effect long term outcome but that is to be studied. The study requires
only limited time investment from patients (3 digital questionnaires and one
additional ultrasound).
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
• Patients undergoing their first CS (planned or emergency)
• >=18 years old
• Sufficient command of the Dutch language
Exclusion criteria
• Patients with an indication for an emergency CS (suspicion of fetal distress)
• Inadequate possibility for counseling (e.g. patients in heavy pain without
accurate therapy, insufficient language comprehension) who were not asked to
sign informed consent earlier in the pregnancy
• Previous uterine major surgery (e.g. laparoscopic or laparotomic fibroid
resection, septum resection)
• Patients with known causes of menstrual disorders (known cervical dysplasia,
communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing
ovulation)
• Placenta percreta during the current pregnancy
• >= 3 fetus during the current pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55551.029.15 |