Medical Management of Late Intrauterine Death. (INPer)
Cervical Pregnancy, Maternal Care for Late Fetal Death
About this trial
This is an interventional treatment trial for Cervical Pregnancy focused on measuring Isosorbide dinitrate gel solution, late intrauterine death, nitric oxide donors
Eligibility Criteria
Inclusion Criteria:
- Closed cervix without evidence of cervical dilation or baseline uterine activity.
- A Bishop score of <5, having intact membranes.
- Gestation greater than or equal to 20 weeks established by the date of menstruation or by fetometry and ultrasound-confirmed late IUFD.
Exclusion Criteria:
- Multiple pregnancies.
- IUFD after late foeticide or the management of specific medical conditions associated with an increase in the risk of IUFD.
- Patients with a history of hypertension.
- Women with a history of unexplained antepartum haemorrhage, pelvic dystocia or any another counter-indications where medications were used.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
isosorbide dinitrate-oxytocin
misoprostol-oxytocin
Preinduction with isosorbide dinitrate gel solution (80 mg/1.5 mL) were administered in the posterior fornix every 3 hours. Once a Bishop score of over 7 was reached, oxytocin was infused in a balanced electrolyte solution beginning with an infusion rate of 2 milli-International Units per minute (mIU/min) and doubling the dose every 15 minutes. If the cervical conditions (<7 Bishop Score) did not change after the treatment application, a new dose, without exceeding 4 doses, to facilitate cervical ripening.
Preinduction with misoprostol gel solution (100 mcg/1.5 mL) were administered in the posterior fornix every 3 hours. Once a Bishop score of over 7 was reached, oxytocin was infused in a balanced electrolyte solution beginning with an infusion rate of 2 milli-International Units per minute (mIU/min) and doubling the dose every 15 minutes. If the cervical conditions (<7 Bishop score) did not change after the treatment application, participants received a new dose, without exceeding 4 doses, to facilitate cervical ripening.