The value of amniopatch in pregnancies associated with spontaneous preterm premature rupture of fetal membranes: a randomized controlled trial

Abstract

Objective: To evaluate the efficacy and safety of amniopatch in pregnancies associated with spontaneous preterm premature rupture of fetal membranes (PPROM).

Methods: A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34 weeks of gestational age. Participants were randomized equally into two groups. Group I in which amniopatch was done in addition to the routine management. Group II was treated with routine management including antibiotics and corticosteroids.

Results: Amniopatch was successful in complete sealing of the membrane defect in 6/50 (12%) of women while none the control group have undergone similar sealing (p = .0144, RR = 0.88). Women in the amniopatch group showed a significant increase of AFI compared to controls (12 versus 0, p = .0001, RR = 0.56).

Conclusion: The amniopatch procedure is a successful technique that safely enhances sealing of fetal membranes and restore the AFI.

Clinical trial registration: NCT03473210

Synopsis

The amniopatch procedure is a successful technique that could be done safely to enhance sealing the fetal membranes and restoring the AFI after PPROM.

Keywords:

• Amniopatch
• preterm labor
• preterm prelabor rupture of membrane (PPROM)

View addendum:

Expression of Concern: The value of amniopatch in pregnancies associated with spontaneous preterm premature rupture of fetal membranes: a randomized controlled trial

Acknowledgment

The authors deeply thanking Nurul Ameen Aasurmade Madappuram, assistant professor of obstetrics and gynecology, Calicut Medical College, India, for his scientific guidance, language revision and re-editing.

Disclosure statement

No potential conflict of interest was reported by the authors.