Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01555671
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 2
• Actual Duration (Months): 42
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

This study aims to evaluate the effect of meperidine on the length of active phase of labor in nulliparous or multiparous women, who will be randomized into two (control and study) groups. Our hypothesis is that the use of meperidine during active labor has no effect on the duration of labor.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Meperidine; Drug: Saline	Phase 4

Detailed Description

• Our aim is to examine the effect of the opioid derivative meperidine used during labor on the duration of labor in singleton pregnancies.

• The sample size was calculated using the Number Cruncher Statistical System (NCSS) / PASS 2007. Power 80% and significance level (α) 0.05, the mean (mean) ± standard deviation (SD) of the first 20 individuals included in the control group of the study (296.04 ± 170.02) and has minimal clinical significance for the active phase of labor from previous studies. We found that the sample size should be 200 (100/100) considering the duration (30 minutes).

• A Simple randomisation using a random-number table was performed by the independent nurse staff, who took no further part in the study.Using the sealed envelope technique, parturients were randomly allocated to two groups: A meperidine group and B normal saline group

• Age, height, weight, body mass index (BMI), gravida, parity, week of gestation, expected fetal weight (EFW), hemoglobin (Hb) and hematocrit (Hct) values and episiotomy requirements were recorded in two groups.Gender, birth weight, 1st and 5th minute Apgar scores and presence of meconium aspiration of the newborns in two groups were recorded.

• During labor, oxytocin induction was not performed during the latent phase in accordance with the routine protocol of our hospital. Pregnant women in both groups were given oxytocin (Synpitan® amp) at a concentration of 1% by 10 drops/min by performing amniotomy when Bishop score was 6 or cervix dilation was 4 cm and when 70% effacement was achieved. In the meperidine group, when the cervical opening was 6 cm and 70% washout, 25 mg iv bolus injection of meperidine (2.5 ml) was administered. The same amount (2.5 ml) of physiological saline was administered intravenously to the subjects in the control group. The patients were followed in NST until 10 cm clearance and 100% effacement. This time was recorded as active phase time. The time from the end of the active phase period to the birth of the baby was recorded as the duration of the second phase of birth.

• The primary outcome of interest in this study is the duration of active phase of labor .

Study Design

• Study Type: Interventional
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized parallel double blind plasebo controlled studyRandomized parallel double blind plasebo controlled study
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Both drug provider and patient do not know which drug or placebo was given
• Primary Purpose: Supportive Care
• Official Title: Is There Any Effect of Meperidine on the Length of Duration of Labor? A Prospective Randomized Controlled Trial.
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: meperidine administration group 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.	Drug: Meperidine; 0.5 ml meperidine injection intravenously injected in randomly selected patients; Other Names: Aldolan 100 mg/2 ml
Placebo Comparator: plasebo group 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.	Drug: Saline; 0.5 ml saline solution injection intravenously injected in randomly selected patients; Other Names: 0.90% w/v of NaCl

Outcome Measures

Primary Outcome Measures

1. The Duration of Active Phase of Labour [24h]

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

Secondary Outcome Measures

1. Total Duration of Labour [24h]

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

2. Duration of the Second Stage of Labour [24h]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• gestational age between 38 and 42 weeks

• live fetus

• cephalic presentation

• in active phase of labour

Exclusion Criteria:

• placenta previa, placental abruption

• caesarean section or any uterine scarring

• multiple gestation

• fetal macrosomia (≥4000 g)

• meperidine allergy

• use any kind of labour induction or augmentation before on admission for delivery in our hospital

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof.Dr.Cemil Tascioglu City Hospital	Istanbul		Turkey	34384

Sponsors and Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

Investigators

• Study Director: Orhan SAHIN, MD, Ministery of Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• meperidine,duration of labor,induction of labor

Publications

None provided.

• Responsible Party: Orhan SAHIN, M.D., MD,, Kanuni Sultan Suleyman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT01555671
• Other Study ID Numbers: 02-11-11-Rev-1
• First Posted: Mar 15, 2012
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Orhan SAHIN, M.D., MD,, Kanuni Sultan Suleyman Training and Research Hospital: labor,; meperidine,; active phase,; duration of labor
• Additional relevant MeSH terms: Labor Pain; Meperidine

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	Study Group	Plasebo Group	Total
Arm/Group Description	0.5 ml meperidine injection intravenously injected in randomly selected patients	0.5 ml saline solution injection intravenously injected in randomly selected patients	Total of all reporting groups
Overall Participants	125	125	250
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	125 100%	125 100%	250 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.21 (5.17)	26.03 (4.8)	25.83 (5.06)
Sex: Female, Male (Count of Participants)
Female	125 100%	125 100%	250 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Turkey	125 100%	125 100%	250 100%

Outcome Measures

1. Primary Outcome

Title	The Duration of Active Phase of Labour
Description	The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor
Time Frame	24h

Outcome Measure Data

Analysis Population Description

women giving birth at term period

Arm/Group Title	Meperidine Administration Group	Plasebo Group
Arm/Group Description	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	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
Measure Participants	105	100
Mean (Standard Deviation) [minutes]	249 (122)	304 (167)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Meperidine Administration Group, Plasebo Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	30
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Total Duration of Labour
Description	Total time of delivery of patients who gave birth including the second stage of delivery
Time Frame	24h

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Meperidine Administration Group	Plasebo Group
Arm/Group Description	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	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
Measure Participants	105	100
Mean (Standard Deviation) [minutes]	273 (129)	331 (177)

3. Secondary Outcome

Title	Duration of the Second Stage of Labour
Description	The period of time until the birth of the baby, since the patient being followed for delivery
Time Frame	24h

Outcome Measure Data

Analysis Population Description

duration of the second stage of labour

Arm/Group Title	Meperidine Administration Group	Plasebo Group
Arm/Group Description	Meperidine: 0.5 ml meperidine injection intravenously injected in randomly selected patients	Saline: 0.5 ml saline solution injection intravenously injected in randomly selected patients
Measure Participants	105	100
Mean (Standard Deviation) [minutes]	24 (15)	27 (22)

Adverse Events

Time Frame	24h
Arm/Group Title	Study Group		Control Group
Arm/Group Description
All Cause Mortality
	Study Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Study Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/105 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Study Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/105 (19%)		4/100 (4%)
Gastrointestinal disorders
emezis	20/105 (19%)	24	4/100 (4%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.