Second Trimester Pregnancy Termination in Women With Previous Caesarean Sections

What Was Tested

The trial (not phased) is built around Oxytocin.

It had two arms (groups): Group I (Misoprostol group): (active comparator) and Group II (Combined group): (active comparator).

The registry classes the interventions as procedure.

More on the Plan

Study participants: the study will include women indicated for termination of pregnancy between 14weeks-23 weeks and 6 days of gestation.

The investigators will involve patients with a singleton pregnancy with one or multiple cesarean delivery.

The investigators will exclude all patients with critical co-morbidities: bleeding disorders, chorioamnionitis, low-lying placenta, rupture uterus, myomectomy and contraindication to misoprostol or latex allergy.

All women will undergo history taking, general examination, and local assessment for the cervix.

Who Took Part

Enrollment: 158 planned participants were the target.

It was open to women only aged from 17 years up to 42 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women indicated for termination of pregnancy between 14weeks-23 weeks and 6 days of gestation. One or multiple cesarean delivery.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: bleeding disorders; low-lying placenta; history of rupture uterus.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2020-07-15 with completion listed for 2021-01.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: time to cervical dilatation in hours (time frame: 24 hours). induction abortion interval in hours (time frame: 48 hours). need for surgical evacuation (time frame: 48 hours).

It also tracked 4 secondary outcomes, for example sever hemorrhage, patients satisfaction, post-abortive infection and rupture uterus.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 158 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.