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IRCT20230526058296N1 IRCT 2023-07-12 Mashhad University of Medical Sciences The effect of sweet almond oil vaginal suppository on the ripening of the cervix The effect of sweet almond oil vaginal suppository on the ripening of the cervix in primiparous women 2023-06-27 anticipated 66 Complete https://irct.ir/trial/70535 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The cases are selected as available and the allocation of eligible pregnant women to the intervention and control groups will be done randomly and with a random sequence created by the website www.randomizer.org. These sequences are produced as quadruple blocks with equal number of A and B (coded by A and B), Blinding description: The drug and placebo are blinded by the pharmacist. The researcher and the participants will not know the contents of the package. The desired suppositories will be prepared in the same size and color with a weight of 3 grams, and the coding on the envelopes (A and B) will be done by the pharmacist consultant. 33 participants in each group will randomly receive suppositories A or B. 3 Ripening of the cervix. Intervention 1: Intervention group: The intervention group uses one 20% sweet almond oil vaginal suppository every night before going to bed for 7 days after determining Bishop's score from the 40th week of pregnancy. If labor does not start, refer three days and one week later to determine Bishop's score and perform a non-stress test (NST). If the labor does not start until the 41st week, the mother will be referred to the maternity hospital to terminate the pregnancy. Intervention 2: Control group: The control group uses a placebo every night before going to bed for 7 days after determining Bishop's score from the 40th week of pregnancy. If labor does not start, refer three days and one week later to determine Bishop's score and perform a non-stress test (NST). If the labor does not start until the 41st week, the mother will be referred to the maternity hospital to terminate the pregnancy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Still undecided - no release schedule yet
public Parisa Hosseini Balajourshari
School of Nursing and Midwifery,Doktora Crossroads, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Hoseinibp4001@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh zahra karimi
School of Nursing and Midwifery ,Doktota Crossroads, ,DaneshgahStreet,
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Karimifz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) primiparous women 18 to 35 years Gestational age 40 weeks Singleton pregnancy Cephalic presentation Body mass index 18.5 to 30 Intact fetal membranes no drug addiction Bishop score 6 or less Reactive non-stress test 18 years 35 years Female Sensitivity to sweet almond oil Medical and obstetric problems O80.0 Spontaneous vertex delivery Other Placebo Intervention group: The intervention group uses one 20% sweet almond oil vaginal suppository every night before going to bed for 7 days after determining Bishop's score from the 40th week of pregnancy. If labor does not start, refer three days and one week later to determine Bishop's score and perform a non-stress test (NST). If the labor does not start until the 41st week, the mother will be referred to the maternity hospital to terminate the pregnancy. Control group: The control group uses a placebo every night before going to bed for 7 days after determining Bishop's score from the 40th week of pregnancy. If labor does not start, refer three days and one week later to determine Bishop's score and perform a non-stress test (NST). If the labor does not start until the 41st week, the mother will be referred to the maternity hospital to terminate the pregnancy. Ripening of the cervix. Timepoint: Before intervention,3 days,1 week after intervation and at the time of hospitalization. Method of measurement: Examination. Onset of labor. Timepoint: Before intervention,3 days,1 week after intervation and at the time of hospitalization. Method of measurement: Examination. Mashhad University of Medical Sciences Approved 2023-06-06 Ethics Committee of Mashhad University of Medical Sciences Assistance of Research and Technology of Mashhad University of Medical Sciences, Qurashi building, Daneshgah avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)