Pethidine Analgesia on Labor Duration

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03882814
Collaborator
Gaziosmanpasa Research and Education Hospital (Other)
240
1
11
21.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
240 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Pethidine Analgesia on Labor Duration and Maternal-Fetal Outcomes
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kanuni Sultan Süleyman Training and Research Hospital Istanbul Turkey 33404

Sponsors and Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital
  • Gaziosmanpasa Research and Education Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pınar Kadirogulları, principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT03882814
Other Study ID Numbers:
  • 2018.37
First Posted:
Mar 20, 2019
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pınar Kadirogulları, principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2020