Cesarean Section ComplicationsPhase 4NCT04364607
IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia
A Phase 4 study testing Neostigmine and NaCl 0.9% in people with Cesarean Section Complications, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Neostigmine and NaCl 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2020to 26 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women undergoing elective cesarean deliver under spinal anesthesia.
Who cannot join
- The age of the patient is more than 35 years of less than 20 years.
- The body mass index of the patient is more than 35 kg/m2 or her height is more than 180 cm or less than 150 cm.
- Multiple gestation.
- The patient is in active labor.
- Vaginal bleeding, placenta previa or abruption of the placenta.
- Presence of fetal distress.
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- Urinary symptoms.
- Medical disorders co-existing with or complicating pregnancy.
- Contraindications for or history of adverse reaction of Neostigmine.
- Contraindication for spinal anesthesia.
- Refusal of the patient to receive spinal anesthesia.
- Intraoperative significant hemorrhage.
- Duration of the operation is more than one hour.
- Occurrence of postoperative complications as eclampsia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section by Spinal Anesthesia
The aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia
Read the detailed description
Following cesarean delivery, women will receive either 0.5 mg IM neostigmine (study group) or IM NaCl 0.9% (control group). Bladder ultrasonography will be done every hour until spontaneous voiding occurs. If postoperative urine retention occurred (void inability with bladder volume > 600 ml by ultrasound), urinary catheterization will be done.
- Conditions
- Cesarean Section Complications
- Being tested
- Neostigmine, NaCl 0.9%
- Keywords
- Cesarean Section, Spinal anesthesia, Postoperative urine retention (POUR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
Also called Epistigmin
Participants will receive 0.5 mg IM neostigmine
NaCl 0.9%Drug
Also called Normal Saline
Participants will receive IM NaCl 0.9% as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine group | Active comparator | After cesarean delivery, women will receive 0.5 mg IM neostigmine Receives: Drug: Neostigmine |
| Placebo group | Placebo comparator | After cesarean delivery, women will receive IM NaCl 0.9% as a placebo Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first voiding after treatment
Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding
Measured: Until 12 hours postoperatively
Time to first voiding after catheter removal
Time interval between catheter removal and occurrence of first voiding
Measured: Until 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start5 Aug 2020
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aml M Aljaml, Principal investigator, Mansoura UniversityMohamed A Elnegery, MD, Study director, Mansoura UniversityNermeen M Shams-Eldien, MD, Study director, Mansoura UniversityKhalid Samir, MD, Study director, Mansoura UniversityMohamed S Abdelhafez, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364607
- Sponsor's protocol ID
- MS.19.12.937.R1
- Status last verified
- Jun 2023
- First submitted
- 24 Apr 2020
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section by Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04364607
- Acronym / sponsor ID
- MS.19.12.937.R1
- Conditions
- Cesarean Section Complications
- Keywords
- Cesarean Section, Spinal anesthesia, Postoperative urine retention (POUR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 28 Apr 2020 (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 aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia
Detailed description
Following cesarean delivery, women will receive either 0.5 mg IM neostigmine (study group) or IM NaCl 0.9% (control group). Bladder ultrasonography will be done every hour until spontaneous voiding occurs. If postoperative urine retention occurred (void inability with bladder volume > 600 ml by ultrasound), urinary catheterization will be done.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neostigmine group | Active comparator | Drug: NeostigmineAfter cesarean delivery, women will receive 0.5 mg IM neostigmine |
| Placebo group | Placebo comparator | Drug: NaCl 0.9%After cesarean delivery, women will receive IM NaCl 0.9% as a placebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women undergoing elective cesarean deliver under spinal anesthesia.
Key exclusion criteria (14 listed)
- The age of the patient is more than 35 years of less than 20 years.
- The body mass index of the patient is more than 35 kg/m2 or her height is more than 180 cm or less than 150 cm.
- Multiple gestation.
- The patient is in active labor.
- Vaginal bleeding, placenta previa or abruption of the placenta.
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 |
|---|---|---|
| NeostigmineAlso: EpistigminParticipants will receive 0.5 mg IM neostigmine | Drug | Neostigmine group |
| NaCl 0.9%Also: Normal SalineParticipants will receive IM NaCl 0.9% as a placebo | Drug | Placebo group |
Primary outcome
Time to first voiding after treatment
Time frame: Until 12 hours postoperatively
Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding
Time to first voiding after catheter removal
Time frame: Until 12 hours postoperatively
Time interval between catheter removal and occurrence of first voiding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Aml M Aljaml principal investigator
Mansoura University
Mohamed A Elnegery, MD study director
Mansoura University
Nermeen M Shams-Eldien, MD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neostigmine and NaCl 0.9% in people with Cesarean Section Complications, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 14 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: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first voiding after treatment (time frame: Until 12 hours postoperatively). 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?
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 7 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.