Mid Trimester Abortion Effectiveness by Dilapan s

Ain Shams Maternity Hospital

Status: Unknown

Conditions: Abortion Early

Treatments: Drug: Misoprostol; Device: Dilapan s

Study type: Interventional

Funder types: Other

Identifiers

NCT05147857

MTD

Details and patient eligibility

About

This study is done aiming to find out an effective method to induce second trimester abortion within a reasonable time and with the least possible cost and complications.

Full description

od complete history taking and examination will be performed including measurement of blood pressure, pulse and temperature. Skin was examined for petichae or ecchymosis to exclude coagulation defects or blood diseases. The abdominal examination included detection of the size of the uterus (in cm above symphysis pubis), presence of scar of previous laparotomy, tenderness or rigidity. The local examination included detection of uterine size by bimanual examination, cervical dilatation, consistency, effacement, and position.

Each patient was investigated for hemoglobin content, Rh-typing, blood sugar level, Coagulation profile, renal function tests, and liver function tests.

Our patients were divided into 2 groups, each containing-- patients: In the First group, induction of abortion was carried out by prostaglandin E1 methyl analogue, Misoprestol. It was given by vaginal routeIn the second group, induction of abortion will be started with Dilapan.s followed by surgical evacuation In the First group, the initial Bishop score will be recorded and the minimal dose of one tablet was inserted deep in the posterior fornix. The dose will be repeated every 4 hours till the products of conception are expelled. If remnants of conception are retained for more than 30 minutes, oxytocin drip will be initiated starting with a minimal dose of 2.5 U in 500-ml glucose 5%. Failure of induction was considered if uterine contractions and start of expulsion had not occurred within 36 hours from initiation of therapy.

In the second group, The vagina will be prepared with Povidine iodine as an antiseptic, which is also used to moisten the dilators. A sterile speculum will be inserted and after inspection of the cervix, the anterior lip will stabilized with ring forceps. Using gentle traction on the cervix, the Dilapan dilator will be inserted into the cervical canal, the upper vagina will then packed with a sterile gauze to maintain the dilator in place. The dilators were left for a period not less than 6 and not more than 24 hours. After removal of the gauze, the Dilapan handle will be grasped with forceps and removed with gentle steady downward traction on Dialpan loop itself. The cervical dilatation will be measured by Hegar's dilators and recorded. Surgical evacuation will then carried out under general anesthesia. In cases with gestational age more than 16 weeks, an oxytocin infusion will be MasterDegreeThesis/MFA/ISRO/FacultyOfMedicine/ASU Page 4

added to induce uterine contractions and expulsion of the contents. Failure was considered if dilatation of the cervix was not achieved, or if there was no response to oxytocin within 36 hours.

Clinical data were recorded in an investigative report form and Sudent's (t) test was used to compare means, P value of < 0.05 was considered significant.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Inclusion Criteria:

• Sure indication of abortion.
• Estimated gestational age between 12-24 weeks as calculated from last normal menstrual period (LNMP) and confirmed by abdominal ultrasound.
• Intact membranes.
• No medical disorder prevents the usage of any of the medications in the study.

Exclusion Criteria:

• History of cervical surgery or presence of cervical scarring.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Mesotac in mid trimester

Active Comparator group

Description:

Prostaglandin

Treatment:

Drug: Misoprostol

Dilapan s in mid trimester

Active Comparator group

Description:

is an osmotic hygroscopic dilator produced from a patented Aquacryl® hydrogel that guarantees consistency of action. It is a rigid gel rod that increases in volume by absorbing fluids from the cervical canal, so it gradually dilates the cervix The thin 4 mm rod can expand up to 15 mm over a 12-24 hours period. This allows it to dilate and soften the cervix gradually.

Treatment:

Device: Dilapan s