Fetal outcomes of the spinal painless vaginal delivery compared to combined spinal-epidural painless vaginal delivery with due attention to newborns' APGAR (Appearance, Pulse, Grimace, Activity, Respiration) scores in first, fifth and tenth minutes

Newborns first, fifth and tenth minutes APGAR scores during painless delivery using spinal analgesia compared to combined spinal-epidural analgesia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016071925821N3

Enrollment

Registered

2016-08-17

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: Spinal analgesia group: during delivery 25 to 50 microgram intrathecal fentanyl injection to L4-L5 as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and du

Prevention

Spinal analgesia group: during delivery 25 to 50 microgram intrathecal fentanyl injection to L4-L5 as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and duration

Combined spinal-epidural group: during delivery intrathecal injection of 3 millimeter 1.5% lidocaine combined with 8 to 10 milligram of 5 mg/ml bupivacaine with 0.0625 saturation with 50 microgram fe

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

Measure	Time 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.	—

Measure

Time 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.

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Secondary

Measure	Time 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 breastfeeding. 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.	—

Measure

Time 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 breastfeeding. 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.

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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