Amniotomy for Second-trimester Pregnancy Termination

Assiut University

Status: Completed

Conditions: Abortion, Missed

Treatments: Drug: Oxytocin; Device: Foley catheter balloon; Procedure: Amniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04906278

AM-FO

Details and patient eligibility

About

The termination of abortion is an important issue that has many controversies. The most common time of serious abortion-related complications is the second trimester. Missed abortion is one of the most common indications of termination of pregnancy in the second trimester. Misoprostol and mifepristone are effective drugs for induction of abortion but these drugs are now expensive, and non-available in many developing countries.

The effectiveness of Foley's catheter balloon on cervical ripping for mid-trimester pregnancy termination has been proved before. It can effectually shorten the time of the expulsion of the fetus. Amniotomy defines as an artificial rupture of the membranes; it is an ordinary obstetric practice used mainly in the induction of labor, with good results and less morbidity. The obstetricians used to combine amniotomy with other methods such as prostaglandins or oxytocin to induce labor in a woman with an unfavorable cervix.

Despite plenty of studies that investigated the role of amniotomy for induction of labor but the studies which addressed the role of amniotomy in the induction of second-trimester abortion are very scarce in the literature.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18-40 years old.
• Women who are pregnant in singleton mid-trimester missed abortion (18-26 weeks).
• Bishop's score is ≤ 4.

Exclusion criteria

• Women who delivered before by classic caesarian section or had a history of -myomectomy, hysteroscopic uterine surgery, or cervical surgery like conization.
• Women with multiple gestations.
• Women with ultrasonography evidence of low amniotic fluid volume.
• Women with rupture of fetal membranes.
• Women with evidence of low implanted placenta by ultrasound.
• History or laboratory evidence of intra-uterine infection.
• History is suggestive of latex allergy.
• Women with severe anemia, hypertension, diabetes, or with coagulopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Amniotomy group

Other group

Description:

Amniotomy will be performed by toothed forceps. The handle of the device will be held with one hand outside the vagina while 2 fingers of the opposite hand will be placed in the vagina to guide the tip.

Treatment:

Procedure: Amniotomy

Device: Foley catheter balloon

Drug: Oxytocin

No-amniotomy group

Other group

Description:

No-amniotomy will be done

Treatment:

Device: Foley catheter balloon

Drug: Oxytocin