Trial Outcomes & Findings for Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women (NCT NCT01555671)

NCT ID: NCT01555671

Last Updated: 2021-09-30

Results Overview

The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 250 participants
• Primary outcome timeframe: 24h
• Results posted on: 2021-09-30

Participant Flow

The study was planned to be carried out between January 2012 and May 2012 in Kanuni Sultan Süleyman training and research hospital(Istanbul-Turkey), gynecology and obstetrics department.

A total of 449 patients were included in the study. 199 patients who did not meet the inclusion criteria were excluded from the study. The remaining 250 patients were randomized to the groups.

Participant milestones

Measure	Study Group Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine,0.5ml (Aldolan; Liba Laboratuarları, Istanbul, Turkey) .	Control Group Bag B (placebo group), containing 0.5ml of normal saline solution.
Overall Study STARTED	125	125
Overall Study COMPLETED	105	100
Overall Study NOT COMPLETED	20	25

Reasons for withdrawal

Measure	Study Group Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine,0.5ml (Aldolan; Liba Laboratuarları, Istanbul, Turkey) .	Control Group Bag B (placebo group), containing 0.5ml of normal saline solution.
Overall Study Physician Decision	20	25

Baseline Characteristics

Of the 250 patients included in the study, 45 patients with cesarean indication were excluded from the study and baseline measurements were made on the remaining patient population.

Baseline characteristics by cohort

Measure	Study Group n=125 Participants 0.5 ml meperidine injection intravenously injected in randomly selected patients	Plasebo Group n=125 Participants 0.5 ml saline solution injection intravenously injected in randomly selected patients	Total n=250 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=125 Participants	0 Participants n=125 Participants	0 Participants n=250 Participants
Age, Categorical Between 18 and 65 years	125 Participants n=125 Participants	125 Participants n=125 Participants	250 Participants n=250 Participants
Age, Categorical >=65 years	0 Participants n=125 Participants	0 Participants n=125 Participants	0 Participants n=250 Participants
Age, Continuous	25.21 years STANDARD_DEVIATION 5.17 • n=105 Participants • Of the 250 patients included in the study, 45 patients with cesarean indication were excluded from the study and baseline measurements were made on the remaining patient population.	26.03 years STANDARD_DEVIATION 4.8 • n=100 Participants • Of the 250 patients included in the study, 45 patients with cesarean indication were excluded from the study and baseline measurements were made on the remaining patient population.	25.83 years STANDARD_DEVIATION 5.06 • n=205 Participants • Of the 250 patients included in the study, 45 patients with cesarean indication were excluded from the study and baseline measurements were made on the remaining patient population.
Sex: Female, Male Female	125 Participants n=125 Participants	125 Participants n=125 Participants	250 Participants n=250 Participants
Sex: Female, Male Male	0 Participants n=125 Participants	0 Participants n=125 Participants	0 Participants n=250 Participants
Region of Enrollment Turkey	125 participants n=125 Participants	125 participants n=125 Participants	250 participants n=250 Participants

PRIMARY outcome

Timeframe: 24h

Population: women giving birth at term period

The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor

Outcome measures

Measure	Meperidine Administration Group n=105 Participants Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine (Aldolan; Liba Laboratuarları, Istanbul, Turkey) .Providers and patients were blinded to the contents of the bags until the conclusion of the study. Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. Meperidine: 0.5 ml meperidine injection intravenously injected in randomly selected patients	Plasebo Group n=100 Participants Bag B (placebo group), containing 0.5ml of normal saline solution. Providers and patients were blinded to the contents of the bags until the conclusion of the study.Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. Saline: 0.5 ml saline solution injection intravenously injected in randomly selected patients
The Duration of Active Phase of Labour	249 minutes Standard Deviation 122	304 minutes Standard Deviation 167

SECONDARY outcome

Timeframe: 24h

Population: Total time of delivery of patients who gave birth including the second stage of delivery

Total time of delivery of patients who gave birth including the second stage of delivery

Outcome measures

Measure	Meperidine Administration Group n=105 Participants Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine (Aldolan; Liba Laboratuarları, Istanbul, Turkey) .Providers and patients were blinded to the contents of the bags until the conclusion of the study. Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. Meperidine: 0.5 ml meperidine injection intravenously injected in randomly selected patients	Plasebo Group n=100 Participants Bag B (placebo group), containing 0.5ml of normal saline solution. Providers and patients were blinded to the contents of the bags until the conclusion of the study.Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. Saline: 0.5 ml saline solution injection intravenously injected in randomly selected patients
Total Duration of Labour	273 minutes Standard Deviation 129	331 minutes Standard Deviation 177

SECONDARY outcome

Timeframe: 24h

Population: duration of the second stage of labour

The period of time until the birth of the baby, since the patient being followed for delivery

Outcome measures

Measure	Meperidine Administration Group n=105 Participants Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine (Aldolan; Liba Laboratuarları, Istanbul, Turkey) .Providers and patients were blinded to the contents of the bags until the conclusion of the study. Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. Meperidine: 0.5 ml meperidine injection intravenously injected in randomly selected patients	Plasebo Group n=100 Participants Bag B (placebo group), containing 0.5ml of normal saline solution. Providers and patients were blinded to the contents of the bags until the conclusion of the study.Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. Saline: 0.5 ml saline solution injection intravenously injected in randomly selected patients
Duration of the Second Stage of Labour	24 minutes Standard Deviation 15	27 minutes Standard Deviation 22

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Study Group n=105 participants at risk	Control Group n=100 participants at risk
Gastrointestinal disorders emezis	19.0% 20/105 • Number of events 24 • 24h	4.0% 4/100 • Number of events 4 • 24h

Additional Information

Orhan SAHIN

Prof.Dr.Cemil Tascioglu City Hospital

Phone: +90 532 240 00 12

Email: drorhansahin@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place