Sexual Intercourse on Spontaneous Onset of Labor (AchourPrtcol)

February 24, 2025 updated by: Achour Radhouane, Medical School of Tunisia

The Impact of Sexual Intercourse on Spontaneous Onset of Labor

Women included in our study were recruited for a randomized trial on the effect of sexual intercourse to promote the onset of spontaneous labor. For this analysis, our sample was divided into two groups by randomization. The first group (experimental) followed the protocol (sexual intercourse 1 day out of 2 alternating with nipple stimulation alone for 15 minutes three times a day) for 2 weeks. In the control group, sexual relations were neither encouraged nor discouraged. Spontaneous labor prior to the date of scheduled labor induction was the primary outcome. We consider that the result is statistically significant differences when P < 0.05.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants comprised pregnant women who were receiving prenatal care at the Maternity and Neonatology Center in Tunis (CMNT). This study was a quasi-experimental, comparative, longitudinal, prospective, and monocentric over one year, from September 24, 2021, to September 24, 2022.

Women in the study had to be aged between 18 and 45 years and had to be with uncomplicated singleton pregnancies with gestational age of 37 weeks and above, at low risk for complication, with intact membranes, and in cephalic presentation. Exclusion criteria were pregestational or gestational hypertension, preeclampsia, gestational diabetes, epilepsy in the mother, type 1 or 2 diabetes, contraindications to vaginal delivery, any type of hospitalization, increased surveillance due to suspicion of preterm labor, unexplained vaginal bleeding, sexually transmitted disease, or fetal anomalies.

The study involved pregnant women who were randomly assigned to two groups. The protocol involved engaging in sexual intercourse and nipple stimulation 3 times per day for two consecutive weeks with the consecutive days of sexual intercourse and days of nipple stimulation being different. Patients documented their coital activities as well as the frequency of orgasms in their daily journal. There were no prohibitions regarding or promotions of sexual activities for the control group. The main outcome was the onset of labor, which was defined as the presence of effective uterine contraction with changes of the cervix (Bishop score > 5) without using the induction treatments during protocol time or until 41 weeks of pregnancy.

The subjects were divided into experimental and control groups using simple random sampling. To eliminate group-bias during the allocation, a computer assigned a sequence of random numbers to all the participants. To eliminate selection bias, allocation concealment was ensured by using sequentially numbered, sealed, opaque envelopes which were prepared by an otherwise unrelated third party. Age and parity were considered for stratification of cases and controls to have relatively equal distribution across the groups.

Quantitative data were obtained from the women through self-administered questionnaires which focused on sexual activity during pregnancy and at term. A chi-square test was carried out to determine if there is a significant relationship between sexual intercourse and the incidence of spontaneous onset of labor. Data analysis was performed using SPSS 21 stats software, with a level of significance set at 0.05.

Both the study aim, and protocol were approved by the ethics committee of the Maternity and Neonatology center of Tunis. Informed consent was obtained from all participants. Participants' anonymity and data confidentiality were upheld throughout the study.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Tunis
      • Tunis6-TUNISIA, Tunis, Tunisia, 2010
        • Manouba 2010 Tunisia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • We included pregnant women (primiparous or multiparous) who presented to the perinatal consultation of the maternity and neonatology center of Tunis. Their pregnancies are evolving singleton, low risk, with intact membranes and cephalic presentation.

Exclusion Criteria:

  • The non-inclusion criteria were high-risk pregnancies:

    • pregnancy pathologies: pregnancy-induced hypertension, pre-eclampsia, gestational diabetes, pregnancy-induced cholestasis, IUGR.
    • maternal pathologies: epilepsy, type 1 or 2 diabetes.
    • contraindications to vaginal delivery: placenta previa or accreta, history of two (or more) cesarean sections, breech or transverse presentation.
    • hospitalizations and/or increased monitoring during pregnancy related to a threat of premature delivery, undetermined bleeding, sexually transmitted diseases, fetal pathologies and/or malformations.

Patients who did not follow the protocol for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sexual intercourse protocol
Our sample was divided into 2 groups by randomization. The first group (interventional) followed the protocol for 2 weeks. These women were asked to keep a daily diary to record coitus and orgasm activities: the rhythm of sexual intercourse, the nature of the intercourse which must be complete and without a condom.
Behavioral: Sexual intercourse protocol
The study involved pregnant women who were randomly assigned to 2 groups. The protocol involved engaging in sexual intercourse and nipple stimulation 3 times per day for two consecutive weeks with the consecutive days of sexual intercourse and days of nipple stimulation being different. Patients documented their coital activities as well as the frequency of orgasms in their daily journal. There were no prohibitions regarding or promotions of sexual activities for the control group. The main outcome was the onset of labor, which was defined as the presence of effective uterine contraction with changes of the cervix (Bishop score > 5) without using the induction treatments during protocol time or until 41 weeks of pregnancy.
No Intervention: Control group
In the control group, sexual intercourse was neither encouraged nor discouraged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spontaneous onset of labor
Time Frame: the spontaneous onset of laborduring the protocol (during the 15 days of the protocol) or after the end of the protocol and up to 41 weeks.
The judgment criterion is the spontaneous onset of labor defined by effective uterine contractions leading to cervical modification (a favorable Bishop score, i.e. greater than 5), and without resorting to treatment (prepedil gel, maturation by probe, cytotec, etc.) during the protocol (during the 15 days of the protocol) or after the end of the protocol and up to 41 weeks.
the spontaneous onset of laborduring the protocol (during the 15 days of the protocol) or after the end of the protocol and up to 41 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical School of Tunisia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2021

Primary Completion (Actual)

September 24, 2022

Study Completion (Actual)

February 24, 2023

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • T00002515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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