Pethidine Analgesia on Labor Duration

Completed

• Conditions: Labor Pain
• Interventions: Drug: Placebo - Concentrate; Drug: pethidine

• Registration Number: NCT03882814
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Placebo - Concentrate	The patients who received placebo injection were included in the control group. Saline was given in placebo.
Pethidine group / study group	pethidine	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.

Primary Outcome Measures

Name	Time	Method
Active phase of labor with pethidine	during labor	The study group that accepted pethidine injection comprised of 132 patients; The active phase duration was evaluated in minutes.
Labor pain with pethidine	during labor	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.

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey