Niche In CEsarean Scar Trial (NICEST)

NCT05312775 | Recruiting DMC

• 1 other identifier: PSHN.0005.2021
• Study Type: interventional
• Target: 938
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Niche

Keywords

single-layer uterine closure; double-layer uterine closure; niche

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  from delivery to 24 months from delivery

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

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

  from delivery to 6 months from delivery)

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

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

  from delivery to 12 months from delivery

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

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

  from delivery to 18 months from delivery

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

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

  from delivery to 24 months from delivery

Secondary Outcomes (21)

• Number of participants with post-partum hemorrhage.

  Within 24 hours from delivery

• Number of participants having uterine atony

  During operation

• Number of participants with maternal infection

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

• Number of participants having postmenstrual spotting in women with Niche

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

• Duration of postmenstrual spotting in women with Niche

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

Other Outcomes (1)

• Reproductive outcome during 2 years of follow-up

  24 months from delivery

Study Arms (2)

Single-layer uterine closure

ACTIVE COMPARATOR

Women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included

Procedure: Single-layer uterine closure

Double-layer uterine closure

ACTIVE COMPARATOR

Women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. 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

Procedure: Double-layer uterine closure

Interventions

Double-layer uterine closure PROCEDURE

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

Double-layer uterine closure

Single-layer uterine closure PROCEDURE

The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included

Single-layer uterine closure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who undergo a primary CD (planned or unplanned)
• Age ≥ 18 years.
• Gestational age ≥ 37 0/7 weeks

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nguyen Thi Thu Ha: lead

Study Sites (1)

Hanoi Obstetrics and Gynecology Hospital

Hanoi, Hanoi, 100000, Vietnam

RECRUITING

Related Publications (13)

• Delport S. Global epidemiology of use of and disparities in caesarean sections. Lancet. 2019 Jul 6;394(10192):23-24. doi: 10.1016/S0140-6736(19)30717-2. Epub 2019 Jul 4. No abstract available.

  PMID: 31282354 BACKGROUND

• Naji O, Wynants L, Smith A, Abdallah Y, Saso S, Stalder C, Van Huffel S, Ghaem-Maghami S, Van Calster B, Timmerman D, Bourne T. Does the presence of a Caesarean section scar affect implantation site and early pregnancy outcome in women attending an early pregnancy assessment unit? Hum Reprod. 2013 Jun;28(6):1489-96. doi: 10.1093/humrep/det110. Epub 2013 Apr 12.

  PMID: 23585560 BACKGROUND

• Naji O, Wynants L, Smith A, Abdallah Y, Stalder C, Sayasneh A, McIndoe A, Ghaem-Maghami S, Van Huffel S, Van Calster B, Timmerman D, Bourne T. Predicting successful vaginal birth after Cesarean section using a model based on Cesarean scar features examined by transvaginal sonography. Ultrasound Obstet Gynecol. 2013 Jun;41(6):672-8. doi: 10.1002/uog.12423.

  PMID: 23371440 BACKGROUND

• Roberge S, Demers S, Berghella V, Chaillet N, Moore L, Bujold E. Impact of single- vs double-layer closure on adverse outcomes and uterine scar defect: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Nov;211(5):453-60. doi: 10.1016/j.ajog.2014.06.014. Epub 2014 Jun 6.

  PMID: 24912096 BACKGROUND

• Hesselman S, Hogberg U, Ekholm-Selling K, Rassjo EB, Jonsson M. The risk of uterine rupture is not increased with single- compared with double-layer closure: a Swedish cohort study. BJOG. 2015 Oct;122(11):1535-41. doi: 10.1111/1471-0528.13015. Epub 2014 Aug 4.

  PMID: 25088680 BACKGROUND

• Clark EA, Silver RM. Long-term maternal morbidity associated with repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S2-10. doi: 10.1016/j.ajog.2011.09.028. Epub 2011 Oct 6.

  PMID: 22114995 BACKGROUND

• Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.

  PMID: 29536581 BACKGROUND

• Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.

  PMID: 23996650 BACKGROUND

• Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of caesarean section. Cochrane Database Syst Rev. 2014 Jul 22;2014(7):CD004732. doi: 10.1002/14651858.CD004732.pub3.

  PMID: 25048608 BACKGROUND

• Di Spiezio Sardo A, Saccone G, McCurdy R, Bujold E, Bifulco G, Berghella V. Risk of Cesarean scar defect following single- vs double-layer uterine closure: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2017 Nov;50(5):578-583. doi: 10.1002/uog.17401. Epub 2017 Oct 9.

  PMID: 28070914 BACKGROUND

• Hanacek J, Vojtech J, Urbankova I, Krcmar M, Krepelka P, Feyereisl J, Krofta L. Ultrasound cesarean scar assessment one year postpartum in relation to one- or two-layer uterine suture closure. Acta Obstet Gynecol Scand. 2020 Jan;99(1):69-78. doi: 10.1111/aogs.13714. Epub 2019 Sep 26.

  PMID: 31441500 BACKGROUND

• Stegwee SI, Jordans IPM, van der Voet LF, Bongers MY, de Groot CJM, Lambalk CB, de Leeuw RA, Hehenkamp WJK, van de Ven PM, Bosmans JE, Pajkrt E, Bakkum EA, Radder CM, Hemelaar M, van Baal WM, Visser H, van Laar JOEH, van Vliet HAAM, Rijnders RJP, Sueters M, Janssen CAH, Hermes W, Feitsma AH, Kapiteijn K, Scheepers HCJ, Langenveld J, de Boer K, Coppus SFPJ, Schippers DH, Oei ALM, Kaplan M, Papatsonis DNM, de Vleeschouwer LHM, van Beek E, Bekker MN, Huisjes AJM, Meijer WJ, Deurloo KL, Boormans EMA, van Eijndhoven HWF, Huirne JAF. Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - the 2Close study: a multicentre randomised controlled trial. BMC Pregnancy Childbirth. 2019 Mar 4;19(1):85. doi: 10.1186/s12884-019-2221-y.

  PMID: 30832681 BACKGROUND

• Dahlke JD, Mendez-Figueroa H, Maggio L, Sperling JD, Chauhan SP, Rouse DJ. The Case for Standardizing Cesarean Delivery Technique: Seeing the Forest for the Trees. Obstet Gynecol. 2020 Nov;136(5):972-980. doi: 10.1097/AOG.0000000000004120.

  PMID: 33030865 BACKGROUND

Study Officials

• Anh D Nguyen, PhD. MD

  Hanoi Obstetric and Gynecology Hospital

  STUDY DIRECTOR

• Yves Ville, PhD. MD

  Hôpital Necker-Enfants Malades

  STUDY CHAIR

• Ha TT Nguyen, PhD.MD

  Hanoi Obstetric and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

• Giang TT Duong, MD

  Hanoi Obstetric and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ha TT Nguyen, PhD.MD

CONTACT

0989661093; dr.hanguyen@hogh.vn

Giang TT Duong, MD

CONTACT

0084972186390; dttgnts41@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: April 6, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)