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Effect of sufentanil in saddle block on delivery parameters

Evaluation of effect of saddle block with single dose of sufentanil on some delivery parameters in women candidates for normal delivery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190817044544N3
Enrollment
140
Registered
2022-05-28
Start date
2020-12-05
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

vaginal delivery and the effect of saddle block on its parameters.

Interventions

Intervention 1: Pregnant mother whose gestational age is 37 weeks According to the midwifery examination, cervical dilatation is 4 to 5 cm, the mother is in sitting position while receiving intrave

Sponsors

Rafsanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 48 Years

Inclusion criteria

Inclusion criteria: This study is a clinical trial that pregnant nolipar mothers who are candidates for vaginal delivery can enter the study.

Exclusion criteria

Exclusion criteria: 1- mothers who do not have the consent of themselves or the gynecologist to perform saddle technique with intrathecal drug. 2- Platelets less than 100000 3- Taking aspirin warfarin and injectable anticoagulants 4- Taking oral or injectable analgesic 24 hours before delivery 5. Contraindications to vaginal delivery: including pelvic stenosis, non-cephalic presentation, fetal distress, meconium , and other cases identified by a gynecologist during analgesia.6- Maternal addiction

Design outcomes

Primary

MeasureTime frame
The effect of saddle block on intensity of labor pain in the active phase of labor from 4 Cm dilatation to giving birth. Timepoint: Pain a few minutes before injection in the saddle block, pain after injection (15 to 30 minutes), pain immediately after delivery and pain one hour after delivery. Method of measurement: visual analogue scale.;The effect of saddle block on duration of active phase of labor from 4 Cm dilatation to giving birth. Timepoint: from 4 cm Dilatation of cervix Simultaneously with saddle block until giving birth in terms of hours is recorded in check list by painless delivery specialist. Method of measurement: It is recorded in the check list once.

Secondary

MeasureTime frame
Neonate respiratory distress syndrom : Shortly after birth, the baby breathe is grunting and needing supplemental oxygen. Timepoint: Immediately after birth until the first first lactation. Method of measurement: Observe the clinical signs of the infant by the trained person.;Perineal rupture: A rupture between the vagina and anus that the probability of occurrence is between 10 to 20% during vaginal delivery and this rupture is divided into four degrees depending on depth of rupture, which is recorded in the check list according to the midwife examination. Timepoint: Once after the baby is born. Method of measurement: Depending on the depth of perineal rupture, grade one to four.;Instrumental delivery :forceps ,vacuum. Timepoint: one time:delivery time. Method of measurement: forceps,vacuum.;Maternal Satisfaction: After delivery, the mother's satisfaction is questioned. Timepoint: once. Method of measurement: good,intermediate,low.;Frequency of cesarean section: How many mothers enter the study ends in cesarean section?. Timepoint: once. Method of measurement: See the final method of baby birth.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactfatemeh jadidi

Rafsanjan University of Medical Sciences

fa.jadidi.2020@gmail.com+98 34 3428 0038

Outcome results

None listed

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