Cesarean Scar Defect Formation After First Cesarean Section.

NCT03966001 | Unknown

• 1 other identifier: UU-SUAM-2019-8/34
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective observational study which will monitor how cesarean section in the first pregnancy will develop a cesarean scar defect. Patients with planned cesarean section in their first pregnancy and those with an emergency cesarean section will be monitored for one year.

Conditions

Cesarean Section Complications; Cesarean Wound Disruption; Cesarean Wound; Dehiscence

Keywords

Cesarean scar pregnancy; Isthmocele; Uterine niche; Cesarean scar defect

Outcome Measures

Primary Outcomes (1)

• Cesarean Scar Defect (Niche)

  The presence of a "niche" at the site of cesarean delivery scar diagnosed at the time of transvaginal ultrasonography

  10 minutes

Secondary Outcomes (1)

• Postmenstrual spotting

  7-10 days

Study Arms (2)

Planned Cesarean Group

Pregnant women undergoing a planned cesarean section at 38-42 gestational week.

Other: Transvaginal sonography at six months after cesarean section; Other: Transvaginal sonography at twelve months after cesarean section

Emergency Cesarean Group

Pregnant women who are planning to give normal birth between 38-42 weeks of gestation but have to been performed an urgent cesarean section due to an emergency such as acute fetal distress, cephalo-pelvic disproportion or another obstetrical condition.

Other: Transvaginal sonography at six months after cesarean section; Other: Transvaginal sonography at twelve months after cesarean section

Interventions

Transvaginal sonography at six months after cesarean section OTHER

In the sixth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.

Also known as: Transvaginal sonography 6th month after C/S

Emergency Cesarean Group; Planned Cesarean Group

Transvaginal sonography at twelve months after cesarean section OTHER

In the twelfth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.

Also known as: Transvaginal sonography 12th month after C/S

Emergency Cesarean Group; Planned Cesarean Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women at 38-42th gestational weeks.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consists of pregnant patients who are in their 38-42th gestational weeks and who undergo planned or emergency cesarean section.

You may qualify if:

• year-old patients
• Patients who have undergone a planned or emergency cesarean section within the 38-42th gestational week.

You may not qualify if:

• Spontaneous vaginal birth
• Preterm birth
• Pregnant women with an obstetrical or gynecological complication.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Ozluce, 16059, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Antila-Langsjo R, Maenpaa JU, Huhtala H, Tomas E, Staff S. Comparison of transvaginal ultrasound and saline contrast sonohysterography in evaluation of cesarean scar defect: a prospective cohort study. Acta Obstet Gynecol Scand. 2018 Sep;97(9):1130-1136. doi: 10.1111/aogs.13367. Epub 2018 May 29.

  PMID: 29754409 BACKGROUND

• Setubal A, Alves J, Osorio F, Guerra A, Fernandes R, Albornoz J, Sidiroupoulou Z. Treatment for Uterine Isthmocele, A Pouchlike Defect at the Site of a Cesarean Section Scar. J Minim Invasive Gynecol. 2018 Jan;25(1):38-46. doi: 10.1016/j.jmig.2017.09.022. Epub 2017 Oct 9.

  PMID: 29024799 BACKGROUND

• Cali G, Timor-Tritsch IE, Palacios-Jaraquemada J, Monteaugudo A, Buca D, Forlani F, Familiari A, Scambia G, Acharya G, D'Antonio F. Outcome of Cesarean scar pregnancy managed expectantly: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Feb;51(2):169-175. doi: 10.1002/uog.17568.

  PMID: 28661021 BACKGROUND

• Antila-Langsjo RM, Maenpaa JU, Huhtala HS, Tomas EI, Staff SM. Cesarean scar defect: a prospective study on risk factors. Am J Obstet Gynecol. 2018 Nov;219(5):458.e1-458.e8. doi: 10.1016/j.ajog.2018.09.004. Epub 2018 Sep 18.

  PMID: 30240650 RESULT

• Ades A, Parghi S. Laparoscopic Resection of Cesarean Scar Ectopic Pregnancy. J Minim Invasive Gynecol. 2017 May-Jun;24(4):533-535. doi: 10.1016/j.jmig.2016.11.006. Epub 2016 Nov 17.

  PMID: 27867050 RESULT

Study Officials

• Gurkan Uncu, Prof.

  Uludag University Hospital, 16059, Bursa, Turkey

  STUDY DIRECTOR

• Bilge Cetinkaya Demır, Assoc.Prof.

  Uludag University Hospital, 16059, Bursa, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adnan Orhan, M.D.

CONTACT

+905056337102; dr.adnan.orhan@hotmail.com

Isil Kasapoglu, M.D

CONTACT

+905305455848; kasapogluisil@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Researcher, Obstetrician and Gynecologist

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: June 25, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 15, 2020
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within nine months after the study completion.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement form.

Locations

TU (1)