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IRCT20160809029281N3 IRCT 2022-12-16 Yazd University of Medical Sciences Evaluation of the effect of castor oil and evening primrose on cervical ripening Comparision between the effects of castor oil and evening primrose oil on cervical ripening of Nuli Par women 2021-12-13 anticipated 114 Complete https://irct.ir/trial/59943 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples will be selected by easy sampling method and then they will be randomly divided into three groups: intervention 1 (60 cc of castor oil), intervention 2 (1000 cc of evening primrose vaginal capsule) and group 3 (control). And then the random allocation of samples will be such that 114 envelopes will be prepared and named equally with code 1, 2, and 3. The codes will be inside the envelopes and will be closed in the envelopes. Those who choose envelopes with code 1 will be in intervention group 1, those who choose envelopes with code 2 will be in intervention group 2, and those who will choose envelopes with code 3 will be in the control group, Blinding description: Participants do not know how to intervene. 3 cervix ripening. Intervention 1: After taking a stress-free test, the researcher is given group A 60 cc of castor oil (produced by Dineh Aromatic Company). Avoid other traditional methods to start labor and danger signs are taught according to the national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization. Intervention 2: Group B is given 1000 mg vaginal evening primrose capsule (Amin Iran Pharmaceutical Company). The dose of drugs is determined according to the studies performed by the pharmaceutical specialists of Amin Pharmaceutical Company and Dineh Iran Industrial Complex. Traditional abstinence to begin childbirth and danger signs are taught according to national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization. Intervention 3: Control group: group C does not involve any intervention other than routine treatment. Research units are instructed to avoid enema, laxatives, herbal or chemical drugs, or other traditional methods of initiating labor during this period, and danger signs are taught according to the national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization. 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 Not yet published
public Fateme Moshirenia
Timsar Fallahi Ave.yazd Town
yazd Iran (Islamic Republic of) 8943163589 +98 35 3521 1698 f.moshirenia@gmail.com Yazd University of Medical Sciences scientific Fateme Moshirenia
Timsar Fallahi Ave.,yazd Town
yazd Iran (Islamic Republic of) 8943163589 +98 35 3521 1698 f.moshirenia@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iranian citizenship Single twin BiShop score below four4 Tend to have a normal delivery a low-risk pregnancy (no diabetes, no preeclampsia, bleeding, etc.) Age 18-35 years Having h eight shorter than 150 cm Water bag closed Fetal weight according to sono2500-4000 No bleeding diseases Head displayFetal health according to sono Fetal health according to sono No known or systemic chronic diseases in the mother 18 years 35 years Female Use of any narcotics or herbal medicines Any vaginal bleeding Having a midwife with a private Treatment - Other Treatment - Other Treatment - Other After taking a stress-free test, the researcher is given group A 60 cc of castor oil (produced by Dineh Aromatic Company). Avoid other traditional methods to start labor and danger signs are taught according to the national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization. Group B is given 1000 mg vaginal evening primrose capsule (Amin Iran Pharmaceutical Company). The dose of drugs is determined according to the studies performed by the pharmaceutical specialists of Amin Pharmaceutical Company and Dineh Iran Industrial Complex. Traditional abstinence to begin childbirth and danger signs are taught according to national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization. Control group: group C does not involve any intervention other than routine treatment. Research units are instructed to avoid enema, laxatives, herbal or chemical drugs, or other traditional methods of initiating labor during this period, and danger signs are taught according to the national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization Cervical ripening. Timepoint: 40 weeks of pregnancy, 48 hours after intervention. Method of measurement: Determine the B-score score, which includes five characteristics: dilatation, effusion, fetal position, consistency, and cervical condition. The most common scoring system is to predict the success or failure of induction of labor. Yazd University of Medical Sciences Approved 2021-10-31 Ethics Committee in Research Infertility Research Center - Shahid Sadoughi University of Medical Sci Timsar fallahi Ave.,yazd Town yazd Yazd Iran (Islamic Republic of)