Pethidine Analgesia on Labor Duration

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882814
• Other study ID #: 2018.37
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital	Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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