Prevention of adhesions post abortion (papa-study); A multicentre, prospective randomised controlled trial evaluating application of auto-crosslinked hyaluronic acid gel following D&C

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Abstract

Background Intrauterine adhesions (IUAs) are reported after dilatation and curettage (D&C) for miscarriage, with frequency related to number of procedures. IUAs are associated with menstrual disturbances, infertility and obstetric complications. In the PAPA-study we aimed to investigate whether application of auto-crosslinked hyaluronic acid (ACP) gel following D&C for miscarriage reduces the rate and severity of IUAs. Methods We performed a multicentre, open-label, randomised controlled study in one university and seven affiliated hospitals in the Netherlands. Women planned for a D&C for miscarriage, with at least one previous D&C, were randomly assigned (1:1) to either D&C plus intrauterine application of ACP gel (10 ml) immediately after the procedure (intervention group) or D&C alone (control group). Randomisation was done with a web-based concealed allocation and stratified by centre with variable block sizes. Each woman underwent a follow-up hysteroscopy 8-12 weeks after the D&C-procedure. The primary outcome was the amount and severity of IUAs. Results Between December 16, 2011 till April 22, 2015, we randomly assigned 78 women to the intervention group and 74 to the control group. Sixty (78%) of 77 women eligible for assessment in the intervention group and 58 (81%) of 72 women in the control group underwent a hysteroscopy. IUAs were observed in 10 (13%) women in the intervention group compared to 22 (31%) women in the control group (relative risk [RR] 0.43; 95% CI 0.22 to 0.83). The severity of the IUAs and mean adhesion score was significantly lower in the intervention group. Conclusions Application of ACP gel following D&C for miscarriage in women with at least one previous D&C, significantly reduces the incidence and severity of IUAs. Adhesion prevention should be offered to this specific group.
Original languageEnglish
Pages (from-to)S73
JournalGynecological Surgery
Volume13
Issue number1
Publication statusPublished - 2016

Cite this

@article{da0237dcf59b470bb75e8e56f3e2a88b,
title = "Prevention of adhesions post abortion (papa-study); A multicentre, prospective randomised controlled trial evaluating application of auto-crosslinked hyaluronic acid gel following D&C",
abstract = "Background Intrauterine adhesions (IUAs) are reported after dilatation and curettage (D&C) for miscarriage, with frequency related to number of procedures. IUAs are associated with menstrual disturbances, infertility and obstetric complications. In the PAPA-study we aimed to investigate whether application of auto-crosslinked hyaluronic acid (ACP) gel following D&C for miscarriage reduces the rate and severity of IUAs. Methods We performed a multicentre, open-label, randomised controlled study in one university and seven affiliated hospitals in the Netherlands. Women planned for a D&C for miscarriage, with at least one previous D&C, were randomly assigned (1:1) to either D&C plus intrauterine application of ACP gel (10 ml) immediately after the procedure (intervention group) or D&C alone (control group). Randomisation was done with a web-based concealed allocation and stratified by centre with variable block sizes. Each woman underwent a follow-up hysteroscopy 8-12 weeks after the D&C-procedure. The primary outcome was the amount and severity of IUAs. Results Between December 16, 2011 till April 22, 2015, we randomly assigned 78 women to the intervention group and 74 to the control group. Sixty (78{\%}) of 77 women eligible for assessment in the intervention group and 58 (81{\%}) of 72 women in the control group underwent a hysteroscopy. IUAs were observed in 10 (13{\%}) women in the intervention group compared to 22 (31{\%}) women in the control group (relative risk [RR] 0.43; 95{\%} CI 0.22 to 0.83). The severity of the IUAs and mean adhesion score was significantly lower in the intervention group. Conclusions Application of ACP gel following D&C for miscarriage in women with at least one previous D&C, significantly reduces the incidence and severity of IUAs. Adhesion prevention should be offered to this specific group.",
keywords = "Netherlands, auto crosslinked hyaluronic acid, clinical trial, control group, controlled clinical trial, controlled study, female, follow up, hospital, human, hysteroscopy, major clinical study, multicenter study, participant observation, prevention, randomization, randomized controlled trial, risk factor, spontaneous abortion, university, uterus synechia",
author = "A Hooker and {De Leeuw}, R and {Van De Ven}, P and H Br{\"o}lmann and J Huirne",
year = "2016",
language = "English",
volume = "13",
pages = "S73",
journal = "Gynecological Surgery",
issn = "1613-2076",
publisher = "Springer Verlag",
number = "1",

}

TY - JOUR

T1 - Prevention of adhesions post abortion (papa-study); A multicentre, prospective randomised controlled trial evaluating application of auto-crosslinked hyaluronic acid gel following D&C

AU - Hooker, A

AU - De Leeuw, R

AU - Van De Ven, P

AU - Brölmann, H

AU - Huirne, J

PY - 2016

Y1 - 2016

N2 - Background Intrauterine adhesions (IUAs) are reported after dilatation and curettage (D&C) for miscarriage, with frequency related to number of procedures. IUAs are associated with menstrual disturbances, infertility and obstetric complications. In the PAPA-study we aimed to investigate whether application of auto-crosslinked hyaluronic acid (ACP) gel following D&C for miscarriage reduces the rate and severity of IUAs. Methods We performed a multicentre, open-label, randomised controlled study in one university and seven affiliated hospitals in the Netherlands. Women planned for a D&C for miscarriage, with at least one previous D&C, were randomly assigned (1:1) to either D&C plus intrauterine application of ACP gel (10 ml) immediately after the procedure (intervention group) or D&C alone (control group). Randomisation was done with a web-based concealed allocation and stratified by centre with variable block sizes. Each woman underwent a follow-up hysteroscopy 8-12 weeks after the D&C-procedure. The primary outcome was the amount and severity of IUAs. Results Between December 16, 2011 till April 22, 2015, we randomly assigned 78 women to the intervention group and 74 to the control group. Sixty (78%) of 77 women eligible for assessment in the intervention group and 58 (81%) of 72 women in the control group underwent a hysteroscopy. IUAs were observed in 10 (13%) women in the intervention group compared to 22 (31%) women in the control group (relative risk [RR] 0.43; 95% CI 0.22 to 0.83). The severity of the IUAs and mean adhesion score was significantly lower in the intervention group. Conclusions Application of ACP gel following D&C for miscarriage in women with at least one previous D&C, significantly reduces the incidence and severity of IUAs. Adhesion prevention should be offered to this specific group.

AB - Background Intrauterine adhesions (IUAs) are reported after dilatation and curettage (D&C) for miscarriage, with frequency related to number of procedures. IUAs are associated with menstrual disturbances, infertility and obstetric complications. In the PAPA-study we aimed to investigate whether application of auto-crosslinked hyaluronic acid (ACP) gel following D&C for miscarriage reduces the rate and severity of IUAs. Methods We performed a multicentre, open-label, randomised controlled study in one university and seven affiliated hospitals in the Netherlands. Women planned for a D&C for miscarriage, with at least one previous D&C, were randomly assigned (1:1) to either D&C plus intrauterine application of ACP gel (10 ml) immediately after the procedure (intervention group) or D&C alone (control group). Randomisation was done with a web-based concealed allocation and stratified by centre with variable block sizes. Each woman underwent a follow-up hysteroscopy 8-12 weeks after the D&C-procedure. The primary outcome was the amount and severity of IUAs. Results Between December 16, 2011 till April 22, 2015, we randomly assigned 78 women to the intervention group and 74 to the control group. Sixty (78%) of 77 women eligible for assessment in the intervention group and 58 (81%) of 72 women in the control group underwent a hysteroscopy. IUAs were observed in 10 (13%) women in the intervention group compared to 22 (31%) women in the control group (relative risk [RR] 0.43; 95% CI 0.22 to 0.83). The severity of the IUAs and mean adhesion score was significantly lower in the intervention group. Conclusions Application of ACP gel following D&C for miscarriage in women with at least one previous D&C, significantly reduces the incidence and severity of IUAs. Adhesion prevention should be offered to this specific group.

KW - Netherlands

KW - auto crosslinked hyaluronic acid

KW - clinical trial

KW - control group

KW - controlled clinical trial

KW - controlled study

KW - female

KW - follow up

KW - hospital

KW - human

KW - hysteroscopy

KW - major clinical study

KW - multicenter study

KW - participant observation

KW - prevention

KW - randomization

KW - randomized controlled trial

KW - risk factor

KW - spontaneous abortion

KW - university

KW - uterus synechia

M3 - Article

VL - 13

SP - S73

JO - Gynecological Surgery

JF - Gynecological Surgery

SN - 1613-2076

IS - 1

ER -