Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar

NCT03859258 | Completed

• 1 other identifier: CSD1
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate different factors affecting niche development in the uterine cesarean section scar in women enrolled 3 to 6 months after cesarean delivery using both TVS and SIS.

Conditions

Cesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (1)

• Rate of Niche development in the uterine cesarean section scar

  Measure number of patients that will develop uterine Niche following lower segment cesarean section

  baseline

Secondary Outcomes (6)

• Measuring Residual myometrial thickness (RMT)

  baseline

• Measuring depth of uterine Niche

  baseline

• Measuring width of uterine Niche

  baseline

• Assessment of potential risk factors for Niche development

  baseline

• Rate of postmenstrual spotting in patients with uterine Niche

  baseline

Study Arms (2)

Patient having Cesarean section

Transvaginal sonography for patients having ceserean section to assess uterine Niche development and parameters

Device: Transvaginal sonography

Patient delivered vaginally

Transvaginal sonography for patients having vaginal delivery to confirm absence of uterine Niche development

Device: Transvaginal sonography

Interventions

Transvaginal sonography DEVICE

Niche is assessed using TVS, SIS (cases only) and office hysteroscopy

Also known as: SIS, office hysteroscopy

Patient delivered vaginally; Patient having Cesarean section

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• Cases are delivered by Lower segment cesarean section
• Controls are delivered vaginally
• Singleton fetus
• Living fetus
• Term pregnancy

You may not qualify if:

• Placenta praevia
• Congenital fetal anomalies
• Severe oligohydramnios(MVP \<2cm)
• Rupture of membranes more than 18 hours
• Puerperal pyrexia or sepsis
• Bladder injury
• Blood transfusion

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 113411, Egypt

Location

Related Publications (19)

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  PMID: 21670862 BACKGROUND

• Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.

  PMID: 17302638 BACKGROUND

• Bij de Vaate AJ, Brolmann HA, van der Voet LF, van der Slikke JW, Veersema S, Huirne JA. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting. Ultrasound Obstet Gynecol. 2011 Jan;37(1):93-9. doi: 10.1002/uog.8864.

  PMID: 21031351 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

• 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

• Deng W, Klemetti R, Long Q, Wu Z, Duan C, Zhang WH, Ronsmans C, Zhang Y, Hemminki E. Cesarean section in Shanghai: women's or healthcare provider's preferences? BMC Pregnancy Childbirth. 2014 Aug 22;14:285. doi: 10.1186/1471-2393-14-285.

  PMID: 25148697 BACKGROUND

• Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.

  PMID: 26409016 BACKGROUND

• Feng XL, Wang Y, An L, Ronsmans C. Cesarean section in the People's Republic of China: current perspectives. Int J Womens Health. 2014 Jan 9;6:59-74. doi: 10.2147/IJWH.S41410. eCollection 2014.

  PMID: 24470775 BACKGROUND

• Hofmeyr GJ, Hannah M, Lawrie TA. Planned caesarean section for term breech delivery. Cochrane Database Syst Rev. 2015 Jul 21;2015(7):CD000166. doi: 10.1002/14651858.CD000166.pub2.

  PMID: 26196961 BACKGROUND

• Monteagudo A, Carreno C, Timor-Tritsch IE. Saline infusion sonohysterography in nonpregnant women with previous cesarean delivery: the "niche" in the scar. J Ultrasound Med. 2001 Oct;20(10):1105-15. doi: 10.7863/jum.2001.20.10.1105.

  PMID: 11587017 BACKGROUND

• Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.

  PMID: 21858885 BACKGROUND

• Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.

  PMID: 19499514 BACKGROUND

• Osterman MJ, Martin JA. Primary cesarean delivery rates, by state: results from the revised birth certificate, 2006-2012. Natl Vital Stat Rep. 2014 Jan;63(1):1-11.

  PMID: 24461076 BACKGROUND

• POIDEVIN LO. The value of hysterography in the prediction of cesarean section wound defects. Am J Obstet Gynecol. 1961 Jan;81:67-71. doi: 10.1016/s0002-9378(16)36308-6. No abstract available.

  PMID: 13736585 BACKGROUND

• Roberts CL, Algert CS, Nippita TA, Bowen JR, Shand AW. Association of prelabor cesarean delivery with reduced mortality in twins born near term. Obstet Gynecol. 2015 Jan;125(1):103-110. doi: 10.1097/AOG.0000000000000578.

  PMID: 25560111 BACKGROUND

• Silver RM. Delivery after previous cesarean: long-term maternal outcomes. Semin Perinatol. 2010 Aug;34(4):258-66. doi: 10.1053/j.semperi.2010.03.006.

  PMID: 20654776 BACKGROUND

• Thurmond AS, Harvey WJ, Smith SA. Cesarean section scar as a cause of abnormal vaginal bleeding: diagnosis by sonohysterography. J Ultrasound Med. 1999 Jan;18(1):13-6; quiz 17-8. doi: 10.7863/jum.1999.18.1.13.

  PMID: 9952074 BACKGROUND

• van der Voet LF, Bij de Vaate AM, Veersema S, Brolmann HA, Huirne JA. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding. BJOG. 2014 Jan;121(2):236-44. doi: 10.1111/1471-0528.12542.

  PMID: 24373597 BACKGROUND

• Weiniger CF, Lyell DJ, Tsen LC, Butwick AJ, Shachar B, Callaghan WM, Creanga AA, Bateman BT. Maternal outcomes of term breech presentation delivery: impact of successful external cephalic version in a nationwide sample of delivery admissions in the United States. BMC Pregnancy Childbirth. 2016 Jul 8;16(1):150. doi: 10.1186/s12884-016-0941-9.

  PMID: 27392035 BACKGROUND

Study Officials

• Mona M Aboulghar, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hassan M Gaafar, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hisham M Haggag, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 1, 2019
• Study Start: July 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

EG (1)