]>
IRCT20181207041873N3 IRCT 2021-02-16 Iran University of Medical Sciences Comparison of the effect of vaginal misoprostol and evening primrose oil capsules with misoprostol alone on the consequences of abortion in women with intrauterine fetal death Comparison of the effect of vaginal misoprostol and evening primrose oil capsules with misoprostol alone on the consequences of abortion in women with intrauterine fetal death 2021-03-10 anticipated 84 Complete https://irct.ir/trial/53681 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The site https://www.sealedenvelope.com is used for random assignment of people in two groups by four-block size, concealment and blinding, Blinding description: The present study is designed for triple-blind. 1000 mg capsules of evening primrose oil and its placebo are prepared by Darogster Barij Essential Oil Company and are made with specific codes A and B and are completely similar. The contents of the capsule are paraffin. The only pharmacist from the medicinal content of evening primrose oil capsules is known and the patient, researcher and assistant researcher and data analysts, outcome assessors, medical staff are unaware of this content. N/A the consequences of abortion in women with intrauterine fetal death. Intervention 1: The recommended dose of misogyny with FIGO protocol for termination of pregnancy due to intrauterine fetal death is 200 μg vaginal every four hours for a maximum of five doses. For the vaginal misoprostol group with evening primrose oil capsules, a dose of 200 micrograms misoprostol tablets with one 1000 mg evening primrose oil capsule is inserted vaginally up to five doses every 4 hours by a researcher or assistant researcher in the posterior fornix. Before placement, for faster absorption, moisten with 0.9% saline with 2 drops of normal saline and then placement. The clients are also told to place the drugs on the left side 30 minutes after placement. During the period of hospitalization from the time of intervention to the time of fetal and placental abruption, once every four hours and in the first hour after embryo and placenta every half an hour, vital signs of the mother, vaginal bleeding and side effects of drugs are recorded. If necessary, medical treatment is used to eliminate side effects. After the fetus is removed, an oxytocin infusion is given to help expel the placenta, and if the placenta does not come out within an hour or there is heavy bleeding at any stage, the patient becomes a candidate for curettage. Ultrasound is done through the vagina to check for pregnancy residues. The patient's hemoglobin is measured at the time of admission and six hours after the abortion. Pain intensity is measured twice. The first time is before the intervention when the specimens are admitted to the ward, and the second time is after the fetus is expelled. The mother is asked to identify the most pain they had in the period from the beginning of the intervention to the abortion on a visual analog scale. In this study, evening primrose oil capsule and its placebo are made by Daroo Gostar Barij Essential Oil Company. The misoprostol (Cytotec) tablet used in this study is made by of Iran Pharmaceutical Company. The dose of each tablet is 200 micrograms. Intervention 2: In the vaginal misoprostol group alone, it works exactly like the comparison group, except that the placebo of the evening primrose capsule, which is 1000 mg of paraffin and is quite similar to the real drug, is used. Yes - There is a plan to make this available What will be shared: Only part of the information, such as information on the main outcome or the like, can be shared. When: Start the access period 6 months after publishing the results To whom: Data for researchers and people who are engaged in treatment can apply to them. Conditions: Data for researchers and people who are engaged in treatment can apply to them. Where to obtain: by Email hadis1993hashemi@gmail.com How to obtain: by Email hadis1993hashemi@gmail.com Comments: 6 months after publishing the results.
public Masoumeh Farahani
Shohada Square, Kamali St., Kamali Educational and Medical Center
Karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 2021 drfarahani73@yahoo.com Karaj University of Medical Sciences scientific Seyede Batool Hasanpoor-Azghady
آدرس خیابان No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery., Tehran Town,
Tehran Iran (Islamic Republic of) 1907755551 +98 21 2286 0021 hasanpoor.sb@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Married Older and equal to 18 years Gestational age 12 to 20 weeks Having a single fetus according to ultrasound confirmation Initial bishop score less than four BMI less than 30 Indication of termination of pregnancy due to intrauterine death of the fetus with confirmation two ultrasounds 18 years no limit Female Drugs abuse smoking more than ten cigarettes a day History of cesarean section Contraindications to the use of evening primrose include: history of mental illness with phenothiazine, history of epilepsy, schizophrenia, history of bleeding disorders and use of anticoagulants Medical disorders in the mother such as heart disease, lung disease, active liver disease, acute hepatitis Previously known drug allergies to misoprostol include drowsiness, tremors, seizures, shortness of breath, hypotension, and bradycardia (WWW.Drugs.com) Medicinal allergies to evening primrose, including urticaria, wheezing, facial edema, lips, tongue and throat (WWW.Drugs.com) Severe anemia Having cervical anomalies Evening capsule vaginal capsule for two weeks continuous Severe vaginal bleeding Enema Having a history of unsuccessful pregnancy History of using any herbal and chemical drugs to help abortion before admission Contraindications to misoprostol use include: ectopic pregnancy, use of estrodiol-free drugs, symptoms of pelvic infection or sepsis, unstable hemodynamic status, mitral stenosis, glaucoma, asthma, bronchitis O04.9 Medical abortion : complete or unspecified, without complication Treatment - Drugs Placebo The recommended dose of misogyny with FIGO protocol for termination of pregnancy due to intrauterine fetal death is 200 μg vaginal every four hours for a maximum of five doses. For the vaginal misoprostol group with evening primrose oil capsules, a dose of 200 micrograms misoprostol tablets with one 1000 mg evening primrose oil capsule is inserted vaginally up to five doses every 4 hours by a researcher or assistant researcher in the posterior fornix. Before placement, for faster absorption, moisten with 0.9% saline with 2 drops of normal saline and then placement. The clients are also told to place the drugs on the left side 30 minutes after placement. During the period of hospitalization from the time of intervention to the time of fetal and placental abruption, once every four hours and in the first hour after embryo and placenta every half an hour, vital signs of the mother, vaginal bleeding and side effects of drugs are recorded. If necessary, medical treatment is used to eliminate side effects. After the fetus is removed, an oxytocin infusion is given to help expel the placenta, and if the placenta does not come out within an hour or there is heavy bleeding at any stage, the patient becomes a candidate for curettage. Ultrasound is done through the vagina to check for pregnancy residues. The patient's hemoglobin is measured at the time of admission and six hours after the abortion. Pain intensity is measured twice. The first time is before the intervention when the specimens are admitted to the ward, and the second time is after the fetus is expelled. The mother is asked to identify the most pain they had in the period from the beginning of the intervention to the abortion on a visual analog scale. In this study, evening primrose oil capsule and its placebo are made by Daroo Gostar Barij Essential Oil Company. The misoprostol (Cytotec) tablet used in this study is made by of Iran Pharmaceutical Company. The dose of each tablet is 200 micrograms. In the vaginal misoprostol group alone, it works exactly like the comparison group, except that the placebo of the evening primrose capsule, which is 1000 mg of paraffin and is quite similar to the real drug, is used. Mean duration from the beginning of the intervention to embryo expulsion. Timepoint: Beginning of the intervention to embryo expulsion. Method of measurement: Minute. The mean dose of misoprostol. Timepoint: End of intervention. Method of measurement: Microgram. Intensity of pain. Timepoint: End of intervention. Method of measurement: Visual Analogue Scale-VAS. People in need of blood transfusions. Timepoint: Blood transfusion time. Method of measurement: Frequency. People in need of curettage. Timepoint: End of intervention. Method of measurement: Frequency. Side effects of medications (fever, nausea, vomiting, diarrhea, chills). Timepoint: From the beginning of the intervention until one hour after the fetus is expelled. Method of measurement: Frequency. Iran University of Medical Sciences Approved 2021-01-12 Ethics Committees of Iran University of Medical Sciences Hemat Highway next to Milad Tower,Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)