Misoprostol Under Scrutiny: What Safer Alternatives Exist for Induction of Labour?
- Hannah Hunt
- Aug 7
- 2 min read
Recent regulatory scrutiny in Germany has cast a spotlight on misoprostol (Angusta) and its role in labour induction, raising significant safety concerns. As this conversation unfolds across Europe, healthcare professionals are re-evaluating their induction protocols and looking to non-pharmacological methods like DILAPAN-S as a safer alternative.
Why Is Misoprostol Being Questioned?
Reports from German authorities and media investigations have revealed:
A flawed approval process, relying on outdated data from Cytotec, a drug not originally designed for labour induction. 1
No successful bioequivalence study confirming Angusta’s similarity to Cytotec. 2
Inconsistent clinical use, with variable monitoring and unclear dosing standards. 3
Alarming rates of adverse outcomes, including excessive uterine activity and fetal distress. 4
These issues have prompted professional bodies and regulators to call for immediate revisions to induction practices.
COMRED Study: DILAPAN-S vs Misoprostol
A landmark randomised controlled trial, the COMRED study 5, published in Obstetrics & Gynecology (2022), compared the efficacy and safety of oral misoprostol with DILAPAN-S, a non-hormonal, mechanical cervical dilator.
Trial Design
303 women at ≥37 weeks gestation were randomised to receive either:
Oral misoprostol (25 mcg every 2 hours, up to 6 doses), or
DILAPAN-S (synthetic osmotic cervical dilator rods inserted for 12 hours).
The primary outcome was vaginal delivery within 36 hours.
Secondary outcomes included pain, patient satisfaction, safety events, and induction-to-delivery time.
Key Results
Outcome | DILAPAN-S | Misoprostol |
Vaginal delivery within 36 hrs | 61.6% | 59.2% |
Uterine tachysystole (cervical ripening phase) | 25.7% | 53.6% |
Tachysystole with fetal heart changes | 2.6% | 7.3% |
Pain/discomfort | Lower | Higher |
Sleep/rest reported | Better | Poorer |
Conclusion:
DILAPAN-S was non-inferior to misoprostol for achieving timely vaginal delivery, but significantly outperformed misoprostol in safety and patient comfort.
Patients inducing using DILAPAN-S reported lower pain scores, better sleep, and fewer side effects. Notably, uterine tachysystole (excessive uterine contractions) occurred twice as often with misoprostol, often requiring clinical intervention.
Why clinicians are considering DILAPAN-S as an alternative
As a pharma-free, mechanical method, DILAPAN-S offers several practical advantages:
No risk of drug-related systemic side effects
Fewer fetal heart rate complications
No need for continuous monitoring
Ideal for outpatient settings in low-risk pregnancies
The COMRED study adds to an existing and ever-growing body of evidence confirming DILAPAN-S as a safe, effective option for cervical ripening - especially in clinical settings aiming to reduce intervention-related risks.
DILAPAN-S offers a predictable, comfortable, and clinically proven method for cervical ripening, meeting the dual priorities of safety and efficacy.
References
28 May 2025 – ZDF heute
2 July 2025 – Die Zeit
5 June 2025 – Mother Hood e. V.
27 June 2025 – BfArM (Federal Institute for Drugs and Medical Devices)
Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term (COMRED trial). Gavara R. et al. Obstetrics & Gynecology: May, 2022
