Skip to content

Newborns first, fifth and tenth minutes APGAR scores during painless delivery using neuraxial analgesia compared to normal vaginal delivery

Comparing effect of the neuraxial painless vaginal delivery with vaginal delivery on fetal outcomes with due attention to newborns' APGAR scores in first, fifth and tenth minutes

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016010325821N1
Enrollment
300
Registered
2016-07-14
Start date
2016-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery pain and its effect on fetal health condition. Fetus and newborn affected by maternal anaesthesia and analgesia in pregnancy, labour and delivery

Interventions

Intervention 1: Neuraxial method: during delivery 25 to 50 microgram intrathecal fentanyl injection as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and duration. Interve
Prevention
Neuraxial method: during delivery 25 to 50 microgram intrathecal fentanyl injection as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and duration
Control group: vaginal delivery will be performed without intrathecal opioid injection.

Sponsors

Vice Chancellor for Research of Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: There is a possibility of natural birth; There is labor pain and active delivery phase; mother's consent to reduce delivery pain; spouse consent. Exclusion criteria: mother's disinclination to participate; Inability to maintain immobility during procedure; Coagulation disorders and defects in homeostasis; Increased intracranial pressure for any reason; Frank infection at the needle site; Hypersensitivity to local anesthetics or other medications using in this methods; Acute lesions of the central nervous system; Maternal hemodynamic instability (hypovolemia, hypotension); Heart diseases that cardiac output is severely limited; fetal distress.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: before the intervention, Immediately after the intervention, Every 5 minutes until delivery, Immediately after delivery. Method of measurement: visual analogue scale tool.;Apgar. Timepoint: first, fifth and tenth minutes after birth. Method of measurement: Apgar scoring system.;Fetal heart rate. Timepoint: before the intervention, Immediately after the intervention, Every 5 minutes until delivery, Immediately after delivery. Method of measurement: physical examination.

Secondary

MeasureTime frame
Hypotention. Timepoint: before the intervention, immediately after the intervention, every 5 minutes until delivery, immediately after delivery. Method of measurement: Sphygmomanometer tool.;Oxygen saturation level. Timepoint: before the intervention, immediately after the intervention, every 5 minutes until delivery, immediately after delivery. Method of measurement: pulse oximeter.;The first time of breadtfeeding. Timepoint: Immediately after delivery. Method of measurement: Physical examination.;Pain. Timepoint: before the intervention, immediately after the intervention, every 5 minutes until delivery, immediately after delivery. Method of measurement: visual analogue scale tool.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Soleiman Pour

Medicine faculty

soleimanpourh@tbzmed.ac.ir+98 41 3336 4667

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026