Pethidine Analgesia on Labor Duration

The Effect of Pethidine Analgesia on Labor Duration and Maternal-Fetal Outcomes

Although opioid analgesics are used to treat labor pain, there are still concerns about their side effects.

The researchers in this study; aimed to evaluate the effect of pethidine on active phase duration of labor, labor pain and maternal-neonatal.

50 mg pethidine will be administered intramuscularly to the cases to be included in the study group. The patients in the control group will be given placebo injections.

Vital signs of all cases included in the study will be checked at 0, 5, 15, 30, 45 and 60 minutes. Pain will also be assessed by Visual Analogue Scale (VAS) before injection and at the 1st and 2nd hour after injection. Delivery times, maternal side effects, neonatal apgar scores and fetal findings will be recorded.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: pethidine; Drug: Placebo - Concentrate

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 33404
    • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria were nulliparous and multiparous patients with singleton pregnancies between 37 and 41 completed weeks (according to last menstrual period).

Description

Inclusion Criteria:

• nullipar-multiparous patients;
• singleton pregnancies 37- 41 weeks (by the last menstrual period).

Exclusion Criteria:

• maternal respiratory rate < 8 /min,
• maternal bradycardia (<60 bpm),
• major fetal congenital anomalies,
• uterine scar presence from previous pregnancies,
• malpresentation,
• antepartum hemorrhage,
• multiple pregnancy,
• labor induction,
• chronic systemic disease,
• rupture fetal membranes,
• epidural analgesia.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pethidine group / study group; Study group; patients given pethidine; The partogram was recorded during delivery. Cervical examination was performed at 2 hour intervals. Recorded in the file. 4 cm and greater cervical dilatation; 50 mg intramuscular (IM) injection was given to pethidine. 200 Montevideo units uterine contractions were reached. Maternal vital signs, maternal complications and neonatal APGAR scores were recorded by the clinician 0-5-15-30-45-60 minutes after pethidine injection.	Drug: pethidine; Pethidine 50 mg intramuscular (IM) injection was performed when cervical dilatation was at or greater than 4 cm and the cardiotocogram uterine contraction recordings of 200 Montevideo units was reached. Opioid analgesia (pethidine HCl - 50 mg I.M.) was given following amniotomy.
control group; The patients who received placebo injection were included in the control group. Saline was given in placebo.	Drug: Placebo - Concentrate; Intramuscular saline was administered to the control group as placebo. Salin intramuscular (IM) injection was performed when cervical dilatation was at or greater than 4 cm and the cardiotocogram uterine contraction recordings of 200 Montevideo units was reached. salon was given following amniotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active phase of labor with pethidine	The study group that accepted pethidine injection comprised of 132 patients; The active phase duration was evaluated in minutes.	during labor
Labor pain with pethidine	Labor pain VAS scores were determined in both groups just prior to pethidine injection (0.hour), and 1st and 2nd hours after injection. The VAS scale represents pain with a score of 1 to 10. patients scored points on this scale and these scores were recorded. 1 point shows the least pain, 10 points the most-irresistible pain.	during labor

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Collaborators: Gaziosmanpasa Research and Education Hospital

Publications and helpful links

General Publications

• Kadirogullari P, Yalcin Bahat P, Sahin B, Gonen I, Seckin KD. The Effect of Pethidine Analgesia on Labor Duration and Maternal-Fetal Outcomes. Acta Biomed. 2021 May 12;92(2):e2021065. doi: 10.23750/abm.v92i2.10905.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 17, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Analgesia; labor; pethidine; Active Phase
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Meperidine
• Other Study ID Numbers: 2018.37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No