Cervical Preparation, Evening Primorose Oil, Hysteroscopy, Misoprostol
Conditions
Brief summary
This study aimed to compare the efficacy of misoprostol versus intravaginal Evening Primrose Oil capsule as a cervical ripening agent prior to operative hysteroscopy.
Detailed description
Hysteroscopy is an operative procedure in which the gynaecologist directly examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix. Misoprostol is a synthetic Prostaglandins (PGE1) analogue that has been found to be a safe and inexpensive agent for cervical ripening. It is one of the most studied cervical ripening agents used prior to hysteroscopy. Evening primrose oil is derived from the seeds of the evening primrose (Oenothera biennis) plant. It is rich in the essential fatty acid gamma linolenic acid, a fatty acid that the body converts to a hormone like substance called prostaglandin E1.
Interventions
OTHERPrimorose Oil
Patients received evening Primorose Oil.
OTHERMisoprostol
Patients received Misoprostol.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age range from 18-65 years * Patients need operative hysteroscopy
Exclusion criteria
* Pregnant women. * Incompetent cervix. * History of cervical operations like conization. * Contraindications for both drugs (women with bleeding disorders, consumers of anticoagulants, schizophrenic individuals receiving phenothiazine, epileptics and those on medication for antihypertension).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of cervical Ripening | During operative hysteroscopy (2 hours after vaginal administration of the study medication) | Cervical ripening assessed by the interval between insertion of Hegar dilators size 3 and size 10, and by the size of the first Hegar dilator requiring forceful insertion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Bleeding | During operative hysteroscopy (2 hours after vaginal administration of the study medication) | Occurrence of cervical bleeding during cervical entry was recorded. |
| False Passage Formation | During operative hysteroscopy (2 hours after vaginal administration of the study medication) | Occurrence of false passage during cervical instrumentation was recorded. |
| Cervical Laceration | During operative hysteroscopy (2 hours after vaginal administration of the study medication) | Occurrence of cervical laceration during cervical dilatation was recorded. |
| Incidence of drug-related adverse effects | Until completion of the procedure (Up to 2 hours) | Incidence of drug-related adverse effects such as the occurrence of nausea, vomiting, diarrhea, fever, and severe abdominal pain were recorded. |
Countries
Egypt
Outcome results
None listed