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Completed

NCT Number: NCT03882814

Pethidine Analgesia on Labor Duration

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.

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Key information

Conditions

Labor Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pethidine

Drug

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.

Placebo - Concentrate

Drug

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.

Primary outcomes

  1. Active phase of labor with pethidine

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Collaborators

  • Gaziosmanpasa Research and Education Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2019
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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