NCT07730060

Brief Summary

The study evaluates the effect of intraperitoneal saline irrigation before abdominal closure during cesarean section on postoperative infectious morbidity and the incidence of paralytic ileus.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Aug 2027

Study Start

First participant enrolled

July 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 3, 2026

Last Update Submit

July 24, 2026

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (2)

  • Postoperative infectious morbidity within 6 weeks

    defined as fever ≥ 38°C, wound infection, or endometritis.

    6 Week

  • Paralytic ileus

    Time to first passage of flatus in hours, and time to first bowel motion in hours.

    baseline

Secondary Outcomes (2)

  • Length of hospital stay in days

    6 week

  • Readmission rate within 6 weeks

    6 week

Study Arms (2)

Group A

EXPERIMENTAL

Intraperitoneal saline irrigation with 1000 mL warm sterile 0.9% normal saline before abdominal closure.

Procedure: Intraperitoneal Saline Irrigation

Group B

NO INTERVENTION

Standard cesarean section without intraperitoneal saline irrigation.

Interventions

Intraperitoneal Saline IrrigationPROCEDURE

Intraperitoneal irrigation with 1000 mL of warm sterile 0.9% normal saline during cesarean section, followed by complete aspiration before abdominal closure.

Group A

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years
  • Elective CS at term ≥37 weeks
  • Singleton pregnancy
  • Intact membranes
  • BMI 18.5 - 34.9 kg/m²

You may not qualify if:

  • Chorioamnionitis or intrauterine infection
  • Prolonged rupture of membranes \> 18 hours
  • History of previous abdominal surgery other than CS
  • Immunocompromised patients or on corticosteroids
  • Severe anemia Hb \< 8 g/dL
  • Diabetes mellitus or hypertension
  • Placenta previa or accreta spectrum disorders
  • Emergency CS for uterine rupture or severe bleeding
  • Known allergy to normal saline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Aslan Cetin B, Aydogan Mathyk B, Barut S, Koroglu N, Zindar Y, Konal M, Atis Aydin A. The impact of subcutaneous irrigation on wound complications after cesarean sections: A prospective randomised study. Eur J Obstet Gynecol Reprod Biol. 2018 Aug;227:67-70. doi: 10.1016/j.ejogrb.2018.06.006. Epub 2018 Jun 7.

    PMID: 29894926RESULT

  • Eke AC, Shukr GH, Chaalan TT, Nashif SK, Eleje GU. Intra-abdominal saline irrigation at cesarean section: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2016;29(10):1588-94. doi: 10.3109/14767058.2015.1055723.

    PMID: 26291302RESULT

  • Viney R, Isaacs C, Chelmow D. Intra-abdominal irrigation at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2012 Jun;119(6):1106-11. doi: 10.1097/AOG.0b013e3182460d09.

    PMID: 22617574RESULT

  • Harrigill KM, Miller HS, Haynes DE. The effect of intraabdominal irrigation at cesarean delivery on maternal morbidity: a randomized trial. Obstet Gynecol. 2003 Jan;101(1):80-5. doi: 10.1016/s0029-7844(02)02466-3.

    PMID: 12517650RESULT

  • Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.

    PMID: 25479008RESULT

  • Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.

    PMID: 28255256RESULT

  • Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.

    PMID: 26849801RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docter

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 28, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07