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

Not Applicable

• Conditions: the consequences of abortion in women with intrauterine fetal death.; Medical abortion : complete or unspecified, without complication; O04.9

• Registration Number: IRCT20181207041873N3
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean duration from the beginning of the intervention to embryo expulsion. Timepoint: Beginning of the intervention to embryo expulsion. Method of measurement: Minute.

Secondary Outcome Measures

Name	Time	Method
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.