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Investigating of the effect of sublingual misoprostol with folly catheter on cervical ripening

Investigating of the effect of sublingual misoprostol with folly catheter on cervical ripening in Pregnant women with hypertension disorders- A single-blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090525001946N12
Enrollment
150
Registered
2024-12-09
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension disorders. Essential (primary) hypertension

Interventions

Intervention 1: Intervention group: The intervention involves the use of a Foley cervical catheter, specifically a size F16 catheter. First, an aseptic vaginal speculum will be inserted to adequately

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Subjects are pregnant women suffering from blood pressure disorders during pregnancy, referring to Al-Zahra Rasht Hospital, and candidates for termination of pregnancy. Inclusion criteria for the study: 1) pregnant women with Pre-eclampsia or gestational hypertension who are candidates for termination of pregnancy, 2) singleton pregnancy, 3) gestational age equal to 26 weeks or more, 4) absence of active labor, 5) cephalic presentation 6) Unprepared cervix (Bishop score less than or equal to 7), 7) a healthy fetus with normal FHR

Exclusion criteria

Exclusion criteria: Criteria for not entering the study: 1) sensitivity to prostaglandins, 2) previous cesarean delivery, 3) previous uterine scar, 4) macrosomia, 5) fatal fetal anomalies, 6) fetal macrocephaly, 7) placenta previa and other indications for cesarean delivery, 8) unwillingness to participate. In the study, the exit criterion includes: at any time, the patient refuses to continue cooperation.

Design outcomes

Primary

MeasureTime frame
Cervical ripening in the optimal time and reaching a Bishop score of 8 and above. Timepoint: During the entire duration of the interventions, the FHR will be continuously monitored and the patient's clinical condition will be monitored every 2 hours by the corresponding resident. Method of measurement: It will be checked by the resident according to the softness and firmness of the cervix, cervical station, dilation rate up to 2 cm which is mentioned in the Williams text book.;Cervical ripening duration of time. Timepoint: During the entire duration of the interventions, the FHR will be continuously monitored and the patient's clinical condition will be monitored every 2 hours by the corresponding resident. Method of measurement: From the time when the uterus is completely rigid with a high station, until it reaches 2 cm dilatation.

Secondary

MeasureTime frame
The need for induction with oxytocin, the duration of labor (time interval from induction to labor),. Timepoint: During the entire duration of the interventions, the FHR will be continuously monitored and the patient's clinical condition will be monitored every 2 hours by the corresponding resident. Method of measurement: Clinical examinations and observation.;Adverse maternal outcomes such as postpartum hemorrhage, diarrhea, uterine tachysystole, residual placenta, uterine atony, uterine hypertonicity, nausea and vomiting, chills, uterine rupture, and chorioamnionitis. Timepoint: All subjects will be followed up for 24 hours after delivery for any unwanted complications. Method of measurement: Clinical examinations and obtaining the patient's history and observation.;Adverse neonatal outcome, low Apgar score of thenewborns,The need for hospitalization of newborns. Timepoint: Immediately after birth. Method of measurement: Clinical examination, Apgar score less than 7.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Ahmadi vasmeh jani

Rasht University of Medical Sciences

Zahra.ahmadi2023@yahoo.com+98 13 3336 9224

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026