Comparative study on Clinical Outcomes of Legal Abortion with/without Feticide Using Intracardiac Potassium Chloride Injection in Patients with Previous Cesarean Sections: A Randomized Controlled Trial in Iran

Examining the clinical outcomes of abortion with legal medical authorization with and without FETICIDE following potassium chloride injection into the heart of the fetus

Phase-3 Two-armed single-blinded parallel group randomized controlled clinical trial on 80 patients. For randomization, Block Randomization method was used with block size of 4 and allocation ratio of 1:1.

Pregnant women with a previous history of at least one CS with a GA of less than 19 weeks who are candidates for legal abortion due to fetal defects with the permission of a forensic doctor who refer to the Prenatal Clinic of Yas Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran will be evaluated.

Inclusion Criteria: Pregnant women with gestational age (GA)<19 weeks and history of previous cesarean section (CS), candidate for legal abortion. Exclusion Criteria: No consent, GA>19 weeks, No history of CS, No indication for legal abortion, No fetal heart activity, abdominal pain, vaginal bleeding, and PROM.

Patients will be divided into two control and intervention groups (feticide). Patients in the control group were immediately treated with vaginal misoprostol termination of pregnancy according to FIGO 2023 protocol with and without cervical catheter. Patients in the intervention group are first subjected to Feticide by injecting 15% KCL solution into the fetal heart until asystole is confirmed by Doppler ultrasound, and after Feticide, the patient is subjected to termination of pregnancy with misoprostol administration protocol with and without cervical catheter similar to the control group.

Confirmed abortion, Placental retention, Placental remnants, Stillbirth, Treatment duration, Blood loss volume.

The participants were randomly assigned to either group using a block randomization method with a block size of 4 and an allocation ratio of 1:1 to ensure equal distribution across the groups throughout the study period. The randomization sequence was generated using a computer-based random number generator prior to the start of the trial. The block randomization scheme (with a block size of 4) was used to maintain balance between the intervention and control groups, ensuring that for every block of 4 patients, 2 were assigned to the intervention group and 2 to the control group. The sequence was created by an independent statistician who was not involved in the recruitment, data collection, or analysis phases of the trial, thereby ensuring that the randomization process was completely independent. To maintain allocation concealment, the randomization sequence was placed in sequentially numbered, opaque, sealed envelopes. Each envelope contained the group assignment (intervention or control) for a specific participant. These envelopes were identical in appearance and were sealed by an independent third party who had no other role in the trial. The envelopes were kept in a secure location and were only accessed at the point of allocation. When a participant was enrolled and consented to participate in the study, the next envelope in the sequence was retrieved by the study coordinator. The envelope was opened only after the participant's eligibility was confirmed and they had been fully recruited into the study. This process ensured that the allocation was concealed from both the participants and the investigators until the point of randomization, thus preventing any potential bias in participant recruitment or treatment allocation.

Ultrasound examinations after the procedure to confirm legal abortion will be done by an obstetrician who does not know about the treatment received by the patients (intervention or control group).

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