]>
IRCT20210113050028N2 IRCT 2022-05-01 Ardabil University of Medical Sciences Comparison of the effect of vaginal misoprostol and Evening primrose Capsule on the state of delivery m_epc Comparison of the effect of vaginal misoprostol alone and in combination with Evening primrose Capsule on the state of delivery in pregnant women candidate for pregnancy termination 2022-05-21 anticipated 30 Complete https://irct.ir/trial/63088 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided randomly. By preparing 30 packets, 15 packets of group A (1000 mg vaginal capsule of evening primrose with 25 μg of Pfizer vaginal mesopzostol) and 15 packets of group B containing vaginal suppositories and vaginal mesoprostol tablets. Every pregnant woman will give one of the envelopes to the researcher by lot to perform delivery induction for the pregnant woman. The researcher will record all the information by attending the mothers' bedside, Blinding description: The patient receives the drug (misoprostol group and evening primrose group) in sealed packets that are encoded. The coding is done by one of the project partners and the participant, clinical caregiver, outcome assessor, data analyzer will not know the type of drug used. 3 Normal Vaginal Delivery. Intervention 1: Intervention group: Receiving 1000 mg vaginal capsule of evening primrose with the use of 25 μg vaginal mesopzostol by Pfizer. Intervention 2: Control group: Vaginal view medication and vaginal mesoprostol tablets. Yes - There is a plan to make this available What will be shared: All data and results will be published as article When: After completing the research To whom: researchers Conditions: To help spread science Where to obtain: Dr. Nooshin Mobaraki_asl How to obtain: reference article Comments:
public Noushin Mobaraki-asl
Varzesh squere, alavi hospital
Ardabil Iran (Islamic Republic of) 5613974156 +98 45 3323 5861 n.mobaraki@arums.ac.ir Ardabil University of Medical Sciences scientific Noushin Mobaraki-asl
Varzesh squere, alavi hospital
Ardabil Iran (Islamic Republic of) 5613974156 +98 45 3323 5861 n.mobaraki@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Single pregnancy live fetus Fetal weight less than 4 kg Amniotic fluid index more than 5 cm normal fetus NST Bishop score less than 7 Absence of labor pains in the mother 15 years 45 years Female Rupture of membranes Possibility of fetal abnormalities need for urgent delivery Hypersensitivity to prostaglandins and evening primrose History of seizures history of schizophrenia with phenothiazin Prescription Bleeding disorders or taking anticoagulants Fallen in FHR Malpresentation Fetal disorders such as hydrocephalia Treatment - Drugs Treatment - Drugs Intervention group: Receiving 1000 mg vaginal capsule of evening primrose with the use of 25 μg vaginal mesopzostol by Pfizer Control group: Vaginal view medication and vaginal mesoprostol tablets Amount of pain. Timepoint: Pain measurement scale based on counting between two contractions. Method of measurement: Pain scale: The amount of pain between zero no pain and 10 most severe pain possible. Vaginal bleeding. Timepoint: During labor. Method of measurement: The amount of vaginal bleeding. Infant Weight. Timepoint: After birth. Method of measurement: Weighing the baby. Infant APGAR. Timepoint: 0-5-10 minutes after birth. Method of measurement: According to the standard Apgar score of infants. Latent & active phase duration. Timepoint: From the onset of labor symptoms to the end of the active phase. Method of measurement: Latent & active phase duration. Cervical dilatation. Timepoint: 0-10 cm. Method of measurement: Induction of cervical dilatation before and after. Duration of latent phase of labor. Timepoint: from the beginning of contractions to dilatation 3-6 cm. Method of measurement: Vaginal examination. Active phase of labor. Timepoint: From dilatation of 3-6 cm to the birth of a baby. Method of measurement: Vaginal examination. Method of delivery. Timepoint: Decide on the method of termination of labor. Method of measurement: Termination method of pregnancy. The volume of postpartum hemorrhage. Timepoint: Until the end of the labor phase. Method of measurement: Number of bloody pads. Pain intensity. Timepoint: every 30 minutes to 2 hours. Method of measurement: Visual Analogue Scale. Dr. Shahrzad Gorbani(researcher) Approved 2021-03-07 Ethics Committee in Biomedical Research, Ardabil University of Medical Sciences End of Daneshgah St., Administrative Complex of Ardabil University of Medical Sciences Ardabil Ardabil Iran (Islamic Republic of)