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IRCT20100414003706N40 IRCT 2021-11-21 Tabriz University of Medical Sciences Comparison of effect of topical magnesium sulfate and placebo (distilled water) on duration of labor and childbirth experience Effects of topical magnesium sulfate on duration of labor and childbirth experience: a randomized controlled trial 2021-12-10 anticipated 98 Complete https://irct.ir/trial/58323 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation sequence will be generated using stratified block randomization (stratified by previous history of labor and type of labor onset (spontaneous or induction)) with block size of four and allocation ration 1:1 using a computerized program (Randomizer). Sequentially numbered opaque sealed envelopes including syringe containing the drug or placebo will be used to conceal the allocation, Blinding description: Syringes containing 10 mL magnesium sulfate or distilled water (identical in appearance) will be packed in sequentially numbered opaque sealed envelopes. The preparation of the envelopes will be performed by a person non-involved in participant recruitment and data collection. The participants, those involved in the recruitment, allocation and data collection, also analyzer will not be blinded. 3 Prolonged labor. Intervention 1: Intervention group: Just after onset of active phase of labor (cervical dilation of 4-5 cm with regular uterine contractions), 10 mL of magnesium sulfate 50% made by Yara Teb Samen Pharmaceutical Company will be poured on the cervix through a 10 mL syringe during vaginal examination from the fingertips of the examiner, so that the whole cervix is impregnated with it. To better absorption of the drug, the women will be asked to sleep in bed for at least half an hour after pouring the drug. If the amniotic sac ruptures less than half an hour after pouring the drug, another 10 mL of magnesium sulfate will be poured on the cervix after discontinuing the discharge. Intervention 2: Control group: Just after onset active phase of labor (cervical dilation of 4-5 cm with regular uterine contractions), 10 mL of placebo (distilled water) will be poured on the cervix through a 10 mL syringe during vaginal examination from the fingertips of the examiner, so that the whole cervix is impregnated with it. The women will be asked to sleep in bed for at least half an hour after pouring the placebo. If the amniotic sac ruptures less than half an hour after pouring the placebo, another 10 mL of distilled water will be poured on the cervix after discontinuing the discharge. 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 (alizades@tbzmed.ac.ir). How to obtain: The requests should be sent by email and data will be available within two week. Comments:
public Sahar Ruhzendeh
Nursing & Midwifery Faculty, South Shariati Ave., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 Saharruhzendeh10@gmail.com Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-charandabi
South Shariati Ave., Tabriz.
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Women aged 18-35 years, nulliparoue or with 1-2 parous without a history of cesarean section Body mass index 19.8-30 kg/m2 (based on weight of pre-pregnancy or first trimester of pregnancy) A live singleton term fetus (gestational age of 37-41 weeks) in estimated weight 2500 to 4000 g and cephalic presentation Having sufficient literacy to read and understand study questionnaires Spontaneous or non-spontaneous onset of labor process Cervical effacement 40-70% Station -2 to 0 18 years 35 years Female History of infertility Contraindications to vaginal delivery including placental abruption, umbilical cord prolapse, cephalopelvic disproportion (CPD) Fetal heart rate disorders in the pre-intervention stage High risk pregnancy (bleeding in the third trimester, placental abruption, placenta previa, fetal growth disorder, etc.) Risky diseases (such as severe anemia (hemoglobin less than 7 g/dL) or blood disorders, heart disease, lung disease, connective tissue and smooth muscle problems) Unwillingness to participate in the study O63.0 Prolonged first stage (of labor) Treatment - Drugs Treatment - Other Intervention group: Just after onset of active phase of labor (cervical dilation of 4-5 cm with regular uterine contractions), 10 mL of magnesium sulfate 50% made by Yara Teb Samen Pharmaceutical Company will be poured on the cervix through a 10 mL syringe during vaginal examination from the fingertips of the examiner, so that the whole cervix is impregnated with it. To better absorption of the drug, the women will be asked to sleep in bed for at least half an hour after pouring the drug. If the amniotic sac ruptures less than half an hour after pouring the drug, another 10 mL of magnesium sulfate will be poured on the cervix after discontinuing the discharge. Control group: Just after onset active phase of labor (cervical dilation of 4-5 cm with regular uterine contractions), 10 mL of placebo (distilled water) will be poured on the cervix through a 10 mL syringe during vaginal examination from the fingertips of the examiner, so that the whole cervix is impregnated with it. The women will be asked to sleep in bed for at least half an hour after pouring the placebo. If the amniotic sac ruptures less than half an hour after pouring the placebo, another 10 mL of distilled water will be poured on the cervix after discontinuing the discharge. The interval between intervention initiation and childbirth. Timepoint: After delivery. Method of measurement: Timer. Score of maternal birth experience. Timepoint: One month after delivery. Method of measurement: Childbirth Experience Questionnaire 2.0. Score of birth satisfaction. Timepoint: 12-24 h after childbirth. Method of measurement: Birth satisfaction scale-revised questionnaire. Pain intensity. Timepoint: AŁŽbout 30 min before the intervention and then 1, 2 and 3 h after starting the intervention. Method of measurement: Visual Analog Scale. Duration of the second stage of labor. Timepoint: After fetal expulsion. Method of measurement: Timer. Duration of the third stage of labor. Timepoint: After complete expulsion of the placenta. Method of measurement: Timer. Bishop Score. Timepoint: Just before the intervention and 2 h after starting the intervention. Method of measurement: Bishop Scoring Table. Hemoglobin and hematocrit. Timepoint: 12- 24 h after delivery. Method of measurement: Laboratory test. Childbirth fear. Timepoint: At baseline and two h after starting intervention. Method of measurement: Delivery Fear Scale. Severity of postpartum fear. Timepoint: 12-24 h and one Month after delivery. Method of measurement: Wijma Version B scale. Tabriz University of Medical Sciences Approved 2021-10-25 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)