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IRCT20100414003706N32 IRCT 2018-11-22 Tabriz University of Medical Sciences 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 2018-11-21 anticipated 351 Complete https://irct.ir/trial/33720 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: At the two intervention groups, amniotomy will be done for those with intact amniotic sac. A 500 ml ringer serum will then be administered for all of the participants with a controlled infusion pump. In the group with early oxytocin infusion, 5 IU of oxytocin, and in the group with delayed oxytocin infusion, 1 ml of distilled water will be added to the solution. The infusion will be started with 3 drops/min. Then, 3 drops will be added every 20 min until reaching number of uterine contractions to 3/10 min or reaching number of the droplets to 30/min. The investigators and participants will not be aware of the type of intervention (early or delayed) within the first 3 h. In cases with occurrence of any tachycystol or abnormal cardiotocogram, the serum will immediately be replaced with a plain serum ringer. After the 3 h, the serum will be discontinued in the both early and delayed groups and a re-examination will be done by the investigator. In absence of childbirth or inadequate uterine contractions after the 3 h, 5 IU of oxytocin in 500 ml ringer serum be infused for the delayed group, in the same way mentioned for the early infusion group. The third (control) group will receive routine intervention of the hospital, Randomization description: A stratified (based on the two study sites) block randomization with random block sizes of 3, 6, 9 and allocation ratio of 1:1:1 will be used to assign participants into the three groups; group 1: amniotomy with early oxytocin infusion, group 2: amniotomy with delayed oxytocin infusion, and group 3: hospital routine intervention. The sequence will be generated using a computerized program (Randomizer). To conceal the sequence, consecutively numbered opaque sealed envelopes will be used. The sequence generation and preparation of the envelopes will be done by a person not involved in participant recruitment or data collection. N/A Prolonged labor in nulliparous women. 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 ringer's solution will be administered by a controlled infusion pump. The infusion will be started with 3 drops/min. Then 3 drops will be added every 20 min until the number of contractions reaches 3/10 min or the number of droplets reaches 30/min. Intervention 2: Intervention group 2 (delayed oxytocin infusion): If the amniotic sac is intact, amniotomy will be done with an amniotic hook by the investigator. Soon after, a 500 ml plain ringer serum will be administered by a controlled infusion pump. The infusion will be started with 3 drops/min. Then, 3 drops will be added every 20 min. After 3 h, in absence of childbirth or inadequate uterine contractions, 5 IU of oxytocin in 500 ml ringer's solution will be infused with 3 drops/min. Then, 3 drops will be added every 20 min until the number of contractions reaches 3/10 min or the number of droplets reaches 30/min. Intervention 3: Control group: This group will receive routine intervention of the hospital that includes: amniotomy, oxytocin infusion, both, or expected management. Yes - There is a plan to make this available What will be shared: All deidentified IPD can be shared. When: Starting soon after publication of the study results. To whom: Data will be available for researchers working in academic institutions, as well as to chief editor and reviewers of the submitted manuscript. Conditions: The data will be available to researchers upon request and submission of the proposal to perform meta-analysis using IPD. Also, in exceptional cases, data will be made available to chief-editor of the journals for checking. Where to obtain: Refer to the email addresses (jnahaee@yahoo.com, alizades@tbzmed.ac.ir). How to obtain: The requests should be sent by email and data will be available within two week. Comments:
public Jila Nahaee
South Shariati Ave., Tabriz.
Tabriz Iran (Islamic Republic of) 5137975846 +98 41 3479 6770 jnahaee@yahoo.com Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-charandabi
South Shariati Ave., Tabriz.
Tabriz Iran (Islamic Republic of) 5137975846 +98 41 3479 6770 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years no limit Female 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. 063.0 Prolonged first stage of labour Treatment - Drugs Treatment - Drugs Treatment - Other 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 ringer's solution will be administered by a controlled infusion pump. The infusion will be started with 3 drops/min. Then 3 drops will be added every 20 min until the number of contractions reaches 3/10 min or the number of droplets reaches 30/min. Intervention group 2 (delayed oxytocin infusion): If the amniotic sac is intact, amniotomy will be done with an amniotic hook by the investigator. Soon after, a 500 ml plain ringer serum will be administered by a controlled infusion pump. The infusion will be started with 3 drops/min. Then, 3 drops will be added every 20 min. After 3 h, in absence of childbirth or inadequate uterine contractions, 5 IU of oxytocin in 500 ml ringer's solution will be infused with 3 drops/min. Then, 3 drops will be added every 20 min until the number of contractions reaches 3/10 min or the number of droplets reaches 30/min. Control group: This group will receive routine intervention of the hospital that includes: amniotomy, oxytocin infusion, both, or expected management. 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. 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. Tabriz University of Medical Sciences Approved 2018-10-22 Ethics committee of Tabriz University of Medical Sciences No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)