Niche In CEsarean Scar Trial (NICEST)

ConditionNiche

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-60

SponsorNguyen Thi Thu Ha

About this trial

Rationale: Cesarean delivery (CD) rates are increasing rapidly worldwide. The consequences of cesarean section not only affect the next pregnancies such as uterine rupture or malplacentation but also cause many gynecological complications or infertility due to the formation of cesarean scar defect (CSD) or Niche. One of the major factors for Niche formation is the techniques of hysterotomy closure at the time of cesarean delivery. Most common hysterotomy closures include single and double layers closure. However, there is limited literature to prove which technique decreases niche creation and associated gynecological complications.

Objective: To compare the effect of uterine closure techniques during CD on the formation of Niche evaluated on transvaginal ultrasound and gynecological complications.

Study design: a double-blinded, single-center, randomized clinical trial. Setting: Hanoi Obstetrics \& Gynecology Hospital (HOGH), Viet Nam. Study population: All women at gestational age ≥ 37 0/7 weeks who undergo a primary CD (planned or unplanned).

Intervention: After informed consent, women will be randomized to either unlocked single layer closure or unlocked double-layer closures of cesarean uterine scar in a 1:1 ratio Primary outcome: The proportion of Niche over time (at 6, 12, 18, 24 months after CD) in the two groups.

Power calculation: A sample size of 389 women is needed for each group. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Both uterine closure methods followed by the Vietnam Ministry of Health (VN-MOH), transvaginal ultrasound is also not harmful. It is believed that there are no potential increased risks to patients taking part in this trial because of the standard care and management they receive.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women who undergo a primary CD (planned or unplanned)

Age ≥ 18 years.

Gestational age ≥ 37 0/7 weeks

Disqualifiers

Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).

Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.).

Women with dysmenorrhea, dyspareunia, suprapubic pain.

Abnormal placenta: Placenta privia, Placenta percreta… in the current pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

Double-layer uterine closure
Procedure/Surgery
In the intervention group, double-layer closure of the uterus will be performed using unlocked multifilament continuous running sutures for both layers and the endometrial layer will be included in the first layer. The second layer is a continuous running suture that imbricates the first layer
Single-layer uterine closure
Procedure/Surgery
The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included

Treatment groups

938 Participants

are divided into 2 treatment groups

Group A: Single-layer uterine closureActive comparator 1 intervention

Group B: Double-layer uterine closureActive comparator 1 intervention

Trial outcomes

Primary outcomes

The proportion of Niche at 6 months after cesarean delivery of Single-layer uterine closure group

The proportion of Niche at 6 months after cesarean delivery of Single-layer uterine closure group.

Time frame

from delivery to 6 months from delivery

The proportion of Niche at 12 months after cesarean delivery of Single-layer uterine closure group

The proportion of Niche at 12 months after cesarean delivery of Single-layer uterine closure group.

Time frame

from delivery to 12 months from delivery

The proportion of Niche at 18 months after cesarean delivery of Single-layer uterine closure group

The proportion of Niche at 18 months after cesarean delivery of Single-layer uterine closure group.

Time frame

from delivery to 18 months from delivery

The proportion of Niche at 24 months after cesarean delivery of Single-layer uterine closure group

The proportion of Niche at 24 months after cesarean delivery of Single-layer uterine closure group.

Time frame

from delivery to 24 months from delivery

Secondary outcomes

Number of participants with post-partum hemorrhage.

Defined as blood loss more than 1000ml with 24 hours after cesarean delivery

Time frame

Within 24 hours from delivery

Number of participants having uterine atony

Defined as use of two or more uterotonics other oxytocin; other surgical interventions such as compression by hand and/or sutures, uterine arteries ligation, embolization, hypogastric arteries ligation, or balloon tamponade

Time frame

During operation

Number of participants with maternal infection

Maternal infection as defined: * Fever: defined as axillary temperature ≥ 37.5 degrees Celsius. * Start of intravenous broad-spectrum antibiotics (with evidence of infection confirmed by clinical and subclinical presentation) * Endometritis, myometritis or urinary tract infection (proven positive vaginal discharge/urine culture)

Time frame

from delivery until maternal hospital discharge, assessed up to 28 days after delivery

Number of participants having postmenstrual spotting in women with Niche

Postmenstrual spotting is brownish discharge for more than two days at the end of menstruation with a total duration (menstruation and spotting) of more than seven days, or intermenstrual bleeding that starts after the end of menstruation, assessed at 6 months, 12 months, 18 months and 24 months after delivery.

Time frame

from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery

Other outcomes

Reproductive outcome during 2 years of follow-up

Percentage of women that conceived at any time during 2 years of follow-up

Time frame

24 months from delivery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nguyen Thi Thu Ha

Lead sponsor

Hanoi Obstetrics and Gynecology Hospital

Sponsor institution

Source ClinicalTrials.gov

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