Cesarean SectionNCT07730060
Intraperitoneal Saline Irrigation in Cesarean Section
A study testing Intraperitoneal Saline Irrigation in people with Cesarean Section, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Intraperitoneal Saline Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40 years
- Elective CS at term ≥37 weeks
- Singleton pregnancy
- Intact membranes
- BMI 18.5 - 34.9 kg/m²
Who cannot join
- 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
Show all 9Show fewer
- Placenta previa or accreta spectrum disorders
- Emergency CS for uterine rupture or severe bleeding
- Known allergy to normal saline
About this study
Official title: Intraperitoneal Saline Irrigation in Cesarean Section: Effect on Postoperative Infectious Morbidity and Paralytic Ileus ,Randomized Controlled Study.
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.
Read the detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide. Despite advances in surgical techniques, aseptic measures, and perioperative antibiotic prophylaxis, postoperative complications such as infectious morbidity and paralytic ileus remain significant causes of maternal morbidity, prolonged hospital stay, and increased healthcare costs. Postoperative infectious morbidity may include endometritis, wound infection, pelvic abscess, and febrile morbidity, while paralytic ileus may delay recovery, ambulation, and initiation of oral feeding.
Intraperitoneal saline irrigation has been proposed as a simple and inexpensive intraoperative technique that may reduce postoperative complications. Irrigation may help remove blood clots, tissue debris, vernix caseosa, and bacterial contaminants from the peritoneal cavity, thereby decreasing inflammatory response and the risk of postoperative infection. In addition, reducing intra-abdominal irritation may improve bowel motility and decrease the incidence of postoperative paralytic ileus.
However, the effectiveness of intraperitoneal saline irrigation during cesarean section remains controversial. Some studies have suggested potential benefits in reducing postoperative febrile morbidity and improving recovery, while others reported no significant advantage. Due to the limited and conflicting evidence, further randomized controlled studies are needed to evaluate the role of intraperitoneal saline irrigation in cesarean delivery.
Therefore, this study aims to assess the effect of intraperitoneal saline irrigation in cesarean section on postoperative infectious morbidity and paralytic ileus.
- Conditions
- Cesarean Section
- Being tested
- Intraperitoneal Saline Irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal Saline IrrigationProcedure or surgery
Intraperitoneal irrigation with 1000 mL of warm sterile 0.9% normal saline during cesarean section, followed by complete aspiration before abdominal closure.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intraperitoneal saline irrigation with 1000 mL warm sterile 0.9% normal saline before abdominal closure. Receives: Procedure: Intraperitoneal Saline Irrigation |
| Group B | No intervention | Standard cesarean section without intraperitoneal saline irrigation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative infectious morbidity within 6 weeks
defined as fever ≥ 38°C, wound infection, or endometritis.
Measured: 6 Week
Paralytic ileus
Time to first passage of flatus in hours, and time to first bowel motion in hours.
Measured: baseline
Secondary outcomes (2)
Length of hospital stay in days
Measured: 6 week
Readmission rate within 6 weeks
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Abdelbaset Gheiat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730060
- Sponsor's protocol ID
- ISICS
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29894926Eke 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.
PubMed 26291302Viney 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.
PubMed 22617574Harrigill 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.
PubMed 12517650Mackeen 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.
PubMed 25479008Zuarez-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.
PubMed 28255256Betran 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.
PubMed 26849801
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Saline Irrigation in Cesarean Section: Effect on Postoperative Infectious Morbidity and Paralytic Ileus ,Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07730060
- Acronym / sponsor ID
- ISICS
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide. Despite advances in surgical techniques, aseptic measures, and perioperative antibiotic prophylaxis, postoperative complications such as infectious morbidity and paralytic ileus remain significant causes of maternal morbidity, prolonged hospital stay, and increased healthcare costs. Postoperative infectious morbidity may include endometritis, wound infection, pelvic abscess, and febrile morbidity, while paralytic ileus may delay recovery, ambulation, and initiation of oral feeding.
Intraperitoneal saline irrigation has been proposed as a simple and inexpensive intraoperative technique that may reduce postoperative complications. Irrigation may help remove blood clots, tissue debris, vernix caseosa, and bacterial contaminants from the peritoneal cavity, thereby decreasing inflammatory response and the risk of postoperative infection. In addition, reducing intra-abdominal irritation may improve bowel motility and decrease the incidence of postoperative paralytic ileus.
However, the effectiveness of intraperitoneal saline irrigation during cesarean section remains controversial. Some studies have suggested potential benefits in reducing postoperative febrile morbidity and improving recovery, while others reported no significant advantage. Due to the limited and conflicting evidence, further randomized controlled studies are needed to evaluate the role of intraperitoneal saline irrigation in cesarean delivery.
Therefore, this study aims to assess the effect of intraperitoneal saline irrigation in cesarean section on postoperative infectious morbidity and paralytic ileus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Intraperitoneal Saline IrrigationIntraperitoneal saline irrigation with 1000 mL warm sterile 0.9% normal saline before abdominal closure. |
| Group B | No intervention | –Standard cesarean section without intraperitoneal saline irrigation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-40 years
- Elective CS at term ≥37 weeks
- Singleton pregnancy
- Intact membranes
- BMI 18.5 - 34.9 kg/m²
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraperitoneal Saline IrrigationIntraperitoneal irrigation with 1000 mL of warm sterile 0.9% normal saline during cesarean section, followed by complete aspiration before abdominal closure. | Procedure or surgery | Group A |
Primary outcome
Postoperative infectious morbidity within 6 weeks
Time frame: 6 Week
defined as fever ≥ 38°C, wound infection, or endometritis.
Paralytic ileus
Time frame: baseline
Time to first passage of flatus in hours, and time to first bowel motion in hours.
2 secondary outcomes
Length of hospital stay in days
Time frame: 6 week
Readmission rate within 6 weeks
Time frame: 6 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Results publication: PubMed 29894926Aslan 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.
- Results publication: PubMed 26291302Eke 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.
- Results publication: PubMed 22617574Viney 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.
- Results publication: PubMed 12517650Harrigill 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.
- Results publication: PubMed 25479008Mackeen 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.
- Results publication: PubMed 28255256Zuarez-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.
- Results publication: PubMed 26849801Betran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intraperitoneal Saline Irrigation in people with Cesarean Section, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative infectious morbidity within 6 weeks (time frame: 6 Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07730060, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.