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Comparison of Effect of Early and Delayed Oxytocin Infusion on Some Maternal and Neonatal Outcomes in Prolonged Labor

Comparison of the Effectiveness of Amniotomy with Early and Delayed Infusion of Oxytocin on Birth Experiences and Some Maternal and Neonatal Outcomes in Nulliparous Women with Prolonged Labor: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100414003706N32
Enrollment
351
Registered
2018-11-22
Start date
2018-11-21
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Prolonged labor in nulliparous women. Prolonged first stage of labour

Interventions

Intervention 1: Intervention group 1 (early oxytocin infusion): If the amniotic sac is intact, amniotomy will be done with an amniotic hook by the investigator. Soon after, 5 IU of oxytocin in 500 ml

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Nulliparous women during labor with alive singleton fetus at gestational age of 37-41 weeks, Aged 18 years or more, Body mass index of 18.5-30 kg/m2, Cephalic presentation of the fetus, Bishop score of 6 or more with cervical dilatation of 4-6 cm, Prolonged labor: progress of cervical dilatation less than 1 cm/h for 3 h or dilatation arrest for 2 h, with weak uterine contractions (less than 3 contractions in 10 min), Intact amniotic sac or a maximum of 30 min from its rupture, Normal cardiotocogram at the time of admission and recruitment.

Exclusion criteria

Exclusion criteria: History of any incisions on the uterus, Abnormal pelvic dimensions, Abnormal bleeding, Any abnormalities in the genital soft or bone tissue, History of infertility and use of any assisted reproductive techniques in the present pregnancy, Any genital tract infection interfering with vaginal delivery (including genital herpes, fever with unknown cause, ...), Maternal medical illness (diabetes, high blood pressure, heart diseases, epilepsy, ...), Abnormal volume of amniotic fluid, Sustained asynclitisme or persistant posterior position, Severe fetal scalp edema or molding, Estimated fetal weight of more than 4000 g Known severe fetal anomalies interfering with vaginal delivery (hydrocephalus, polycystic kidney and any large abdominal mass) diagnosed, Fetal intrauterine growth restriction (IUGR), Maternal speech, hearing and visual problems.

Design outcomes

Primary

MeasureTime frame
The interval between intervention initiation and vaginal delivery. Timepoint: After delivery. Method of measurement: Timer.;Score of maternal satisfaction with process of labor and birth. Timepoint: 12-24 h after childbirth. Method of measurement: MacKey childbirth satisfaction rating scale.

Secondary

MeasureTime frame
Mode of delivery. Timepoint: After delivery. Method of measurement: Using Medical record.;Uterine hyperstimulation. Timepoint: At intervals of one hour since the intervention initiation. Method of measurement: Palpation of uterine contractions for 10 min.;Maternal fever. Timepoint: Within 6 hours after delivery. Method of measurement: Thermometer (sublingual).;Use of analgesic drugs in the first stage of labor. Timepoint: During intervention. Method of measurement: Observation and record.;Manual removal of placenta. Timepoint: After vaginal childbirth. Method of measurement: Observation.;Hemoglobin and hematocrit. Timepoint: At baseline and 12 hours after delivery. Method of measurement: Laboratory test.;Volume of postpartum hemorrhage. Timepoint: 12 hours after delivery. Method of measurement: Using the Stafford formula.;Duration of the first stage of labor (from 4 to 10 cm cervical dilatation). Timepoint: After completion of cervical dilatation. Method of measurement: Timer.;Duration of the second stage of labor (from completing cervical dilatation to fetal expulsion). Timepoint: After fetal expulsion. Method of measurement: Timer.;Duration of the third stage of labor (from delivery of the baby until complete expulsion of the placenta). Timepoint: After complete expulsion of the placenta. Method of measurement: Timer.;Abnormal cardiotocogram (late deceleration, variable deceleration). Timepoint: During the intervention. Method of measurement: Cardiotocography audit sheet.;Admission in neonatal intensive care unit. Timepoint: At hospital discharge of the baby. Method of measurement: Hospital record.;Neonate Apgar score less than 7. Timepoint: 5 minutes after birth. Method of measurement: Clinical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJila Nahaee

Tabriz University of Medical Sciences

jnahaee@yahoo.com+98 41 3479 6770

Outcome results

None listed

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