Induction of labour with oral misoprostol or Foley catheter at term.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28572

Enrollment

1860

Registered

2012-06-07

Start date

2012-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Induction of labor Misoprostol Foley catheter Inleiden van de bevalling

Interventions

Induction of labor with oral misoprostol 50 ug tablets.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term women (37 weeks and more); 2. Scheduled for induction; 3. Vital singlet in cephalic presentation; 4. Intact membranes; 5. Unfavourable cervix (Bishop score < 6).

Exclusion criteria

Exclusion criteria: 1. History of sectio caesarea; 2. Placenta praevia; 3. Maternal age < 18 years; 4. Lethal congenital malformations.

Design outcomes

Primary

Measure	Time frame
Percentage of post partum hemorrhage (defined as more than 1000 cc blood loss) and asphyxia (defined as an apgar score <7 at 5 minutes and/or umbilical cord Ph < 7.05).	—

Secondary

Measure	Time frame
1. Mode of delivery (Caesarean section, vaginal instrumental delivery) and the reason for instrumental delivery, i.e. suspected fetal distress and arrest of labor; 2. Induction to delivery time; 3. Use of analgesics; 4. Oxytocin use; 5. Maternal morbidity; 6. Maternal post partum blood transfusion; 7. Hyperstimulation (defined as more than five contractions in ten minutes over a minimal period of two times ten minutes with FHR changes) Uterine hypertonus (defined as a contraction lasting more than three minutes with FHR changes); 8. Uterine rupture (separation of the uterine wall); 9. Maternal infection; 10. Fever (defined as a temperature ≥ 37.8 degrees C) during labor or fetal tachycardia and start of antibiotics; 11. Fever (defend as a temperature ≥ 37.8 degrees C) within one week post partum and start of antibiotics; 12. Fetal tachycardia (a sustained fetal heart rate above 160 beats per minute); 13. Start of intravenous broad-spectrum antibiotics Endo(myo)etritis or urinary tract infection within one week post partum (proven positive vaginal discharge/urine culture); 14. Neonatal morbidity; 15. Meconium stained liquor; 16. Apgar scores < 7 at 1 and 5 minutes; 17. Admissions to the neonatal ward/NICU; 18. Women's preference; 19. Costs.	—

Measure

Time frame

1. Mode of delivery (Caesarean section, vaginal instrumental delivery) and the reason for instrumental delivery, i.e. suspected fetal distress and arrest of labor; 2. Induction to delivery time; 3. Use of analgesics; 4. Oxytocin use; 5. Maternal morbidity; 6. Maternal post partum blood transfusion; 7. Hyperstimulation (defined as more than five contractions in ten minutes over a minimal period of two times ten minutes with FHR changes) Uterine hypertonus (defined as a contraction lasting more than three minutes with FHR changes); 8. Uterine rupture (separation of the uterine wall); 9. Maternal infection; 10. Fever (defined as a temperature ≥ 37.8 degrees C) during labor or fetal tachycardia and start of antibiotics; 11. Fever (defend as a temperature ≥ 37.8 degrees C) within one week post partum and start of antibiotics; 12. Fetal tachycardia (a sustained fetal heart rate above 160 beats per minute); 13. Start of intravenous broad-spectrum antibiotics Endo(myo)etritis or urinary tract infection within one week post partum (proven positive vaginal discharge/urine culture); 14. Neonatal morbidity; 15. Meconium stained liquor; 16. Apgar scores < 7 at 1 and 5 minutes; 17. Admissions to the neonatal ward/NICU; 18. Women's preference; 19. Costs.

—

Contacts

Public ContactMieke L.G. Eikelder, ten

probaat2@studies-obsgyn.nl+31 (0)6 14368914

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)