IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2021-10-26

Brief Summary

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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

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Detailed Description

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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

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Neostigmine group

After cesarean delivery, women will receive 0.5 mg IM neostigmine

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Participants will receive 0.5 mg IM neostigmine

Placebo group

After cesarean delivery, women will receive IM NaCl 0.9% as a placebo

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type DRUG

Participants will receive IM NaCl 0.9% as a placebo

Interventions

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Neostigmine

Participants will receive 0.5 mg IM neostigmine

Intervention Type DRUG

NaCl 0.9%

Participants will receive IM NaCl 0.9% as a placebo

Intervention Type DRUG

Other Intervention Names

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Epistigmin Normal Saline

Eligibility Criteria

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Inclusion Criteria

* Pregnant women undergoing elective cesarean deliver under spinal anesthesia.

Exclusion Criteria

* 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.
* 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No