Study: NCT01860521

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Programmed Intermittent Epidural Bolus
Description: An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was \< 30 mm were administered.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Continuous Epidural Infusion
Description: An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was \< 30 mm were administered.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Procedure of interruption of pregnancy
Description: Patients were administered 1 mg of gemeprost pessaries (Cervidil®, Merck Serono SPA, Roma, Italy) in the posterior fornix of the vagina every 3 hours up to 5 doses. If the expulsion of the fetus did not occur, the therapeutic regimen was repeated after 24 hours from the initiation of the treatment. Induction-to-abortion time (hours) was considered the period of time comprised between the first gemeprost pessary administration and fetal expulsion. Failure of induction of abortion was defined as women undelivered after two completed cycles (48h).The evacuation of the uterus under general anesthesia was performed if ultrasonography showed retained productions of conception.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Procedure of interruption of pregnancy
Description: Patients were administered 1 mg of gemeprost pessaries (Cervidil®, Merck Serono SPA, Roma, Italy) in the posterior fornix of the vagina every 3 hours up to 5 doses. If the expulsion of the fetus did not occur, the therapeutic regimen was repeated after 24 hours from the initiation of the treatment. Induction-to-abortion time (hours) was considered the period of time comprised between the first gemeprost pessary administration and fetal expulsion. Failure of induction of abortion was defined as women undelivered after two completed cycles (48h).The evacuation of the uterus under general anesthesia was performed if ultrasonography showed retained productions of conception.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Drug used for analgesia procedures
Description: Levobupivacaine (Chirocaine®, Abbott, Chicago, IL, USA) and sufentanil(Fentatienil®, Angelini, Rome, Italy) were administered in both study groups according to the regimen of each intervention arm (Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Drug used for analgesia procedures
Description: Levobupivacaine (Chirocaine®, Abbott, Chicago, IL, USA) and sufentanil(Fentatienil®, Angelini, Rome, Italy) were administered in both study groups according to the regimen of each intervention arm (Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion).

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pump for programmed intermittent bolus.
Description: Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pump for continuous epidural infusion.
Description: Pump administering continuous epidural infusion for the maintenance of analgesia was used.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Drug used for termination of pregnancy procedure.
Description: Gemeprost pessaries.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Drug used for termination of pregnancy procedure.
Description: Gemeprost pessaries.